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Roxee Meds Catalog

Enrofloxacin

Medication catalog facts with explicit FDA-approval, off-label, source-limited, and safety context.

Both Catalog complete FDA data linked Rx required Tablet Multiple FDA labelers Official label facts Owner quick guide first

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Storefront facts
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May 5, 2026, 10:00 a.m.

These are the storefront facts Roxee uses on browse cards and quick facts.

FDA applications
FDA application data refreshed
May 5, 2026, 10:00 a.m.

Sponsor, product, and application records imported from Animal Drugs @ FDA.

Safety reports
Safety data refreshed
May 5, 2026, 10:01 a.m.

openFDA reaction terms and case summaries are supporting evidence, not proof of causality.

Source timing details
Source timing details
  • Storefront facts: Source Roxee | Refreshed May 5, 2026, 10:00 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Apr 10, 2026, 10:01 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC

Evidence

Reviewed / Updated / Sources

Reviewed by: Not available

Last reviewed: February 12, 2026

Updated: February 12, 2026, 7:40 PM UTC

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Enrofloxacin

Enrofloxacin

Drug type: Generic ingredient • Branded profile FDA branded products available

Both Tablet Rx required 100% storefront ready

Species: Both

Manufacturer: Multiple FDA labelers

Medication Snapshot

Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.

Enrofloxacin

Fluoroquinolone antibiotic used for susceptible bacterial infections. Species commonly shown: Both, Dog, No Use Class Stated Or Implied, Cat, No Use Class Stated Or Implied.

Generic name
Enrofloxacin
Brand names
Baytril™ Antibacterial Tablets Baytril™ Taste Tabs™ Antibacterial Tablets, Baytril™ Antibacterial Injectable Solution, Baytril™ 100, Baytril® 100-CA1
Manufacturer
Multiple FDA labelers
Species
Both, Dog, No Use Class Stated Or Implied, Cat, No Use Class Stated Or Implied, No use class stated or implied
Dosage forms
Tablet, Liquid (Solution), Solution, Injectable Solution
Prescription
Prescription required
Completeness
100%
Validation
Complete
Brand names
Baytril™ Antibacterial Tablets Baytril™ Taste Tabs™ Antibacterial Tablets Baytril™ Antibacterial Injectable Solution Baytril™ 100 Baytril® 100-CA1 Enroflox® 100 Enroflox™ Injection for Dogs 2.27% Zobuxa™ Enrofloxacin Antibacterial Injectable Solution Enrofloxacin Flavored Tablets EnroMed™ 100 Baytril® Soft Chewable Tablets ENROFLOXACIN 100 Tenotryl™ Enrofloxacin Enroflox® Chewable Tablets EnroPro™ 22.7 EnroPro™ 100 Baytril EnroMed Enrofloxacin Flavored Tenotryl Enrosite Flavored Enroquin Flavored Quellaxcin Enrosite Enroflox EnroPro 100 Enroflox 100 Fluroxin Flavored AX Pharmaceutical Corp X Fluroxin for Dogs 2.27% EnroPro 22.7 Enroquin SolutionKits Enrofloxacin Enrofloxacin Base Enrofloxacin HCl
Dosage forms
Tablet Liquid (Solution) Solution Injectable Solution Chewable Tablets Flavored Tablets

Indications / Uses

Fluoroquinolone antibiotic used for susceptible bacterial infections.

Administration / How To Give

Oral

Storage

Store at room temperature away from moisture.

Warnings / Contraindications

Use caution in young/growing animals (joint/cartilage risk). Avoid in pets with known fluoroquinolone sensitivity.

  • Use caution in young/growing animals (joint/cartilage risk). Avoid in pets with known fluoroquinolone sensitivity.

Side Effects

GI upset. In cats, high doses can cause retinal toxicity and vision loss.

FAQ

Both, Dog, No Use Class Stated Or Implied, Cat, No Use Class Stated Or Implied, No use class stated or implied, Beef, excluding veal calves, Dairy, females Under 20 months of age, Replacement dairy heifers under 20 months of age, Beef, except beef calves less than 2 months of age and beef bulls intended for breeding (any age), Beef And Non-Lactating Dairy

Yes. Roxee shows this as prescription-only.

Tablet, Liquid (Solution), Solution, Injectable Solution

Store at room temperature away from moisture.

Source Transparency

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Pet Owner Quick Guide

Start here first for the safest next-step summary before the deeper medication detail.

Used for:

For the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed

Dosing note:

Exact dosing depends on your pet's species, weight, and health status. Use your veterinarian's instructions for the exact dose and schedule.

What to watch for:

  • Use caution in young/growing animals (joint/cartilage risk)
  • Avoid in pets with known fluoroquinolone sensitivity
  • Crust (1 reports)
  • Cough (1 reports)
  • Confusion (1 reports)

When to call the vet:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
  • Facial swelling or hives.
  • Blood in vomit or stool.

What to tell or ask your vet today:

  • Is this medicine the right fit for my pet’s current symptoms?
  • Which warning signs mean I should call back right away?
  • How should I handle missed doses or refusal to take the medicine?
Major cautions & emergency warning signs

Side effects to monitor:

  • Use caution in young/growing animals (joint/cartilage risk)
  • Avoid in pets with known fluoroquinolone sensitivity
  • Crust
  • Cough
  • Confusion

Most reported reactions:

  • Crust (1 reports)
  • Cough (1 reports)
  • Confusion (1 reports)

Emergency warning signs:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.

Videos

Video education and manufacturer materials for Enrofloxacin.

Educational Videos
Manufacturer Videos

Quick Facts

Official label facts first, then secondary summaries. Marketing content is separated below.

Species: Both
Manufacturer: Multiple FDA labelers
Form: Chewable Tablets, Flavored Tablets, Injectable Solution, Liquid (Solution), Solution, Tablet
Identifiers:
ANADA: 200495 ANADA: 200513 ANADA: 200517 ANADA: 200527 ANADA: 200551 ANADA: 200598 ANADA: 200608 ANADA: 200628 ANADA: 200680 ANADA: 200688 ANADA: 200697 ANADA: 200708 ANADA: 200720 ANADA: 200737 ANADA: 200758 ANADA: 200764 ANADA: 200765 ANADA: 200782 ANADA: 200810 NADA: 140441
Source metadata:

Warnings / Contraindications

Use caution in young/growing animals (joint/cartilage risk). Avoid in pets with known fluoroquinolone sensitivity.

  • High: Use caution in young/growing animals (joint/cartilage risk). Avoid in pets with known fluoroquinolone sensitivity.
Source metadata:

Adverse Reactions

Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.

Tap or hover a reaction to see what it means in plain language.

Tracked signals
32
Reported cases
32
Serious reports
29
Species represented
2
Grouped by Body System
Digestive (2) · Loss of appetite, Bloody diarrhoea Neurologic (1) · Unsteady walking (ataxia) Behavior (3) · Circling - behavioural disorder, Biting -aggression, Anxiety Other (26) · Crust, Cough, Confusion
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Other 1 Dog 1
Behavior 1 Dog 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Cat 1

Species coverage: Dog (20) Cat (12)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Neurologic Cat Non-serious - 1
Digestive Dog Non-serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Behavior Dog Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Digestive Cat Serious - 1
Other Cat Serious - 1
Behavior Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Behavior Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Dog Serious - 1
Other Dog Serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Other Dog Non-serious - 1
Other Cat Serious - 1
Source metadata:

Storage & Handling

Store at room temperature away from moisture.

Documents

Owner handouts and official technical documents open on-page first, with the original source still one click away.

Owner handouts

0
No owner handouts linked yet.

Official label / PI

2

SPL

64

FOI

38

141-068

Official label / PI · EA

141-068

Official label / PI · FONSI

Baytril™ 100

SPL · SPL

FDA Structured Product Label

Baytril™ 100

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Elanco US Inc.
NADA
141-068
Status
RX
Form
Solution
Route
Intramuscular, Subcutaneous
Species
No use class stated or implied • Beef, excluding veal calves • Dairy, females Under 20 months of age
Composition / specifications
Each mL of sterile solution contains 100 mg of enrofloxacin.

Swine

Indication
For the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed
Dosage
Administer, either by intramuscular or subcutaneous (behind the ear) injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb). For the control of colibacillosis, administration should be initiated within the first 60 days post-weaning when clinical signs are present in at least 2% of the animals in the group. If no improvement is noted within 48 hours, the diagnosis should be reevaluated.
Indication
For the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae.
Dosage
Administer, either by intramuscular or subcutaneous (behind the ear) injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb).

Cattle (Beef and Non-Lactating Dairy)

Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beef and non-lactating dairy cattle

Dosage

Multiple-day therapy: 2.5 to 5.0 mg/kg of body weight (1.1 to 2.3 mL/100 lb) by subcutaneous injection. Treatment should be repeated at 24-hour intervals for three days. Additional treatments may be given on Days 4 and 5 to animals that have shown clinical improvement but not total recovery. Administered dose volume should not exceed 20 mL per injection site.

Indication
For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni, and Mycoplasma bovis in beef and non-lactating dairy cattle
Dosage

Single-dose therapy: 7.5 to 12.5 mg/kg of body weight (3.4 to 5.7 mL/100 lb) by subcutaneous injection. Administered dose volume should not exceed 20 mL per injection site.

Indication

For the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis

Dosage

Single-dose therapy: 7.5 mg/kg of body weight (3.4 mL/100 lb) by subcutaneous injection. Administered dose volume should not exceed 20 mL per injection site.

Baytril® Antibacterial Tablets

SPL · SPL

FDA Structured Product Label

Baytril™ Antibacterial Tablets Baytril™ Taste Tabs™ Antibacterial Tablets

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Elanco US Inc.
NADA
140-441
Status
RX
Form
Tablet
Route
Oral
Species
Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
Each tablet contains either 22.7, 68.0, or 136 milligrams of enrofloxacin.

Cats

Indication
For management of diseases associated with bacteria susceptible to enrofloxacin.
Dosage
5 milligrams per kilogram (2.27 milligrams per pound) of body weight.

Dogs

Indication
For management of diseases associated with bacteria susceptible to enrofloxacin.
Dosage
5 to 20 milligrams per kilogram (2.27 to 9.07 milligrams per pound) of body weight.

Baytril® Taste Tabs® Antibacterial Tablets

SPL · SPL

FDA Structured Product Label

Baytril™ Antibacterial Tablets Baytril™ Taste Tabs™ Antibacterial Tablets

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Elanco US Inc.
NADA
140-441
Status
RX
Form
Tablet
Route
Oral
Species
Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
Each tablet contains either 22.7, 68.0, or 136 milligrams of enrofloxacin.

Cats

Indication
For management of diseases associated with bacteria susceptible to enrofloxacin.
Dosage
5 milligrams per kilogram (2.27 milligrams per pound) of body weight.

Dogs

Indication
For management of diseases associated with bacteria susceptible to enrofloxacin.
Dosage
5 to 20 milligrams per kilogram (2.27 to 9.07 milligrams per pound) of body weight.

Baytril® Antibacterial Injectable Solution

SPL · SPL

FDA Structured Product Label

Baytril™ Antibacterial Injectable Solution

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Elanco US Inc.
NADA
140-913
Status
RX
Form
Liquid (Solution)
Route
Intramuscular
Species
Dog, No Use Class Stated Or Implied
Composition / specifications
Each milliliter of sterile aqueous solution contains 22.7 milligrams of enrofloxacin.

Dogs

Indication
Dogs for management of diseases associated with bacteria susceptible to enrofloxacin.
Dosage
2.5 milligrams intramuscularly per kilogram (1.13 milligrams per pound) of body weight as a single initial dose only.
Limitations

As a single, intramuscular, initial dose followed by use of tablets twice daily for 2 to 3 days beyond cessation of clinical signs to a maximum of 30 days.

Enrofloxacin Flavored Tablets

SPL · SPL

FDA Structured Product Label

Enrofloxacin Flavored Tablets

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Hikma Pharmaceuticals USA, Inc.
ANADA
200-810
Status
RX
Form
Flavored Tablets
Route
Oral
Composition / specifications
22.7 mg, 68 mg, or 136 mg of enrofloxacin per tablet

Dogs

Indication

For the management of diseases associated with bacteria susceptible to enrofloxacin

Dosage

Administer orally at 5 to 20 milligrams per kilogram (2.27 to 9.07 milligrams per pound) of body weight. The dose may be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals.

Cats

Indication

For the management of diseases associated with bacteria susceptible to enrofloxacin

Dosage

Administer orally at 5 milligrams per kilogram (2.27 milligrams per pound) of body weight. The dose may be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals.

EnroPro™ 100

SPL · SPL

FDA Structured Product Label

EnroPro™ 100

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Cronus Pharma Specialities India Private Ltd.
ANADA
200-765
Status
RX
Form
Injectable Solution
Route
Intramuscular, Subcutaneous
Species
No use class stated or implied • Beef And Non-Lactating Dairy
Composition / specifications
100 mg/mL

Cattle (Beef and Non-Lactating Dairy)

Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beef and non-lactating dairy cattle.

Dosage

Multiple-day therapy: 2.5 to 5.0 mg/kg of body weight (1.1 to 2.3 mL/100 lb) by subcutaneous injection. Treatment should be repeated at 24-hour intervals for three days. Additional treatments may be given on Days 4 and 5 to animals that have shown clinical improvement but not total recovery. Administered dose volume should not exceed 20 mL per injection site.

Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni, and Mycoplasma bovis in beef and non-lactating dairy cattle.

Dosage

Single-dose therapy: 7.5 to 12.5 mg/kg of body weight (3.4 to 5.7 mL/100 lb) by subcutaneous injection. Administered dose volume should not exceed 20 mL per injection site.

Indication

For the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.

Dosage

Single-dose therapy: 7.5 mg/kg of body weight (3.4 mL/100 lb) by subcutaneous injection. Administered dose volume should not exceed 20 mL per injection site.

Swine

Indication

For the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae.

Dosage

Administer, either by intramuscular or subcutaneous (behind the ear) injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb).

Indication

For the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed

Dosage

Administer, either by intramuscular or subcutaneous (behind the ear) injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb). For the control of colibacillosis, administration should be initiated within the first 60 days post-weaning when clinical signs are present in at least 2% of the animals in the group. If no improvement is noted within 48 hours, the diagnosis should be reevaluated.

EnroPro™ 22.7

SPL · SPL

FDA Structured Product Label

EnroPro™ 22.7

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Cronus Pharma Specialities India Private Ltd.
ANADA
200-764
Status
RX
Form
Injectable Solution
Route
Intramuscular
Species
Dog, No Use Class Stated Or Implied
Composition / specifications
22.7 mg/mL (2.27%)

Dogs

Indication

For the management of diseases in dogs associated with bacteria susceptible to enrofloxacin.

Dosage

2.5 milligrams intramuscularly per kilogram (1.13 milligrams per pound) of body weight as a single initial dose only.

Enrofloxacin

SPL · SPL

FDA Structured Product Label

Enrofloxacin

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Felix Pharmaceuticals Pvt. Ltd.
ANADA
200-758
Status
RX
Form
Injectable Solution
Route
Intramuscular, Subcutaneous
Species
No use class stated or implied • Beef And Non-Lactating Dairy
Composition / specifications
100 mg/mL

Cattle (Beef and Non-Lactating Dairy)

Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non-lactating dairy cattle

Dosage

Single-Dose Therapy (BRD Treatment): Administer, by subcutaneous injection, a single dose of 7.5 – 12.5 mg/kg of body weight (3.4 – 5.7 mL/100 lb).

Indication

For the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.

Dosage

Single-Dose Therapy (BRD Control): Administer, by subcutaneous injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb).

Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni in beef and non-lactating dairy cattle.

Dosage

Multiple-Day Therapy (BRD Treatment): Administer daily, a subcutaneous dose of 2.5 – 5 mg/kg of body weight (1.1 – 2.3 mL/100 lb). Treatment should be repeated at 24-hour intervals for three days. Additional treatments may be given on Days 4 and 5 to animals that have shown clinical improvement but not total recovery.

Swine

Indication

For the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae; and for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed.

Dosage

Administer, either by intramuscular or subcutaneous (behind the ear) injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb). Administered dose volume should not exceed 5 mL per injection site. For the control of colibacillosis, administration should be initiated within the first 60 days post-weaning when clinical signs are present in at least 2% of the animals in the group.

Baytril® 100-CA1

SPL · SPL

FDA Structured Product Label

Baytril® 100-CA1

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Elanco US Inc.
NADA
141-527
Status
RX
Form
Injectable Solution
Route
Subcutaneous
Species
Replacement dairy heifers under 20 months of age • Beef, except beef calves less than 2 months of age and beef bulls intended for breeding (any age)
Composition / specifications
100 mg/mL

Cattle (replacement dairy heifers under 20 months of age and all classes of beef cattle except beef calves less than 2 months of age and beef bulls intended for breeding (any age))

Indication

Conditionally approved for the treatment of clinical anaplasmosis associated with Anaplasma marginale in replacement dairy heifers under 20 months of age and all classes of beef cattle except beef calves less than 2 months of age and beef bulls intended for breeding (any age). Not for use in any other class of dairy cattle or in veal calves.

Dosage

Administer as a single dose for treatment of clinical anaplasmosis. Administer, by subcutaneous injection, a single dose of 12.5 mg/kg of body weight (5.7 mL/100 lb). Administered dose volume should not exceed 20 mL per injection site.

Enrofloxacin

SPL · SPL

FDA Structured Product Label

Enrofloxacin

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
ZYVET AH, Inc.
ANADA
200-737
Status
RX
Form
Flavored Tablets
Route
Oral
Species
Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
22.7 mg, 68 mg, or 136 mg of enrofloxacin per tablet

Dogs

Indication

For the management of diseases associated with bacteria susceptible to enrofloxacin

Dosage

Administer orally at a rate to provide 5-20 mg/kg (2.27 to 9.07 mg/lb) of body weight. The dose may be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals. Selection of a dose within the range should be based on clinical experience, the severity of disease, and susceptibility of the pathogen. Animals which receive doses in the upper-end of the dose range should be carefully monitored for clinical signs that may include inappetence, depression, and vomition.

Cats

Indication

For the management of diseases associated with bacteria susceptible to enrofloxacin

Dosage

Administer orally at 5 mg/kg (2.27 mg/lb) of body weight. The dose may be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals. The dose should be continued for at least 2-3 days beyond cessation of clinical signs, to a maximum of 30 days.

Enroflox® Chewable Tablets

SPL · SPL

FDA Structured Product Label

Enroflox® Chewable Tablets

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Norbrook Laboratories, Ltd.
ANADA
200-720
Status
RX
Form
Chewable Tablets
Route
Oral
Species
Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
22.7 mg, 68 mg, or 136 mg of enrofloxacin per tablet

Dogs

Indication

For the management of diseases associated with bacteria susceptible to enrofloxacin.

Dosage

Administer orally at a rate to provide 5-20 mg/kg (2.27 to 9.07 mg/lb) of body weight as a single daily dose or divided into two (2) equal daily doses at twelve (12) hour intervals.

Cats

Indication

For the management of diseases associated with bacteria susceptible to enrofloxacin.

Dosage

Administer orally at 5 mg/kg (2.27 mg/lb) of body weight as a single daily dose or divided into two (2) equal daily doses at twelve (12) hour intervals.

Tenotryl™

SPL · SPL

FDA Structured Product Label

Tenotryl™

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Virbac AH, Inc.
ANADA
200-688
Status
RX
Form
Injectable Solution
Route
Intramuscular, Subcutaneous
Species
No use class stated or implied • Beef And Non-Lactating Dairy
Composition / specifications
100 mg/mL

Beef cattle and non-lactating dairy cattle

Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non-lactating dairy cattle.

Dosage

Administer, by subcutaneous injection, a single dose of 7.5 – 12.5 mg/kg of body weight (3.4 – 5.7 mL/100 lb).

Indication

For the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.

Dosage

Administer, by subcutaneous injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb). Administered dose volume should not exceed 20 mL per injection site.

Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni in beef and non-lactating dairy cattle.

Dosage

Administer daily, a subcutaneous dose of 2.5 – 5 mg/kg of body weight (1.1 – 2.3 mL/100 lb). Treatment should be repeated at 24-hour intervals for three days. Additional treatments may be given on Days 4 and 5 to animals that have shown clinical improvement but not total recovery.

Swine

Indication

For the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae. It is also indicated for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed.

Dosage

Administer, either by intramuscular or subcutaneous (behind the ear) injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb). Administered dose volume should not exceed 5 mL per injection site. For the control of colibacillosis, administration should be initiated within the first 60 days post-weaning when clinical signs are present in at least 2% of the animals in the group.

ENROFLOXACIN 100

SPL · SPL

FDA Structured Product Label

ENROFLOXACIN 100

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Sparhawk Laboratories, Inc.
ANADA
200-628
Status
RX
Form
Injectable Solution
Route
Subcutaneous, Intramuscular
Species
No use class stated or implied • Beef And Non-Lactating Dairy
Composition / specifications
100 mg/mL

Beef cattle, non-lactating dairy cattle

Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non-lactating dairy cattle; and for the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.

Dosage

Administer, by subcutaneous injection, a single dose of 7.5-12.5 mg/kg of body weight (3.4-5.7 mL/100 lb).

Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni in beef and non-lactating dairy cattle.

Dosage

Administer daily, a subcutaneous dose of 2.5-5 mg/kg of body weight (1.1-2.3 mL/100 lb). Treatment should be repeated at 24-hour intervals for three days. Additional treatments may be given on Days 4 and 5 to animals that have shown clinical improvement but not total recovery.

Swine

Indication

For the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae. It is also indicated for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed.

Dosage

Administer, either by intramuscular or subcutaneous (behind the ear) injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb). Administered dose volume should not exceed 5 mL per injection site. For the control of colibacillosis, administration should be initiated within the first 60 days post-weaning when clinical signs are present in at least 2% of the animals in the group.

Enrofloxacin

SPL · SPL

FDA Structured Product Label

Enrofloxacin

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Felix Pharmaceuticals Pvt. Ltd.
ANADA
200-708
Status
RX
Form
Injectable Solution
Route
Intramuscular
Species
Dog, No Use Class Stated Or Implied
Composition / specifications
22.7 mg/mL (2.27%)

Dogs

Indication

For the management of diseases in dogs associated with bacteria susceptible to enrofloxacin.

Dosage

Enrofloxacin Injectable Solution may be used as the initial dose at 2.5 mg/kg. It should be administered intramuscularly (IM) as a single dose, followed by initiation of enrofloxacin tablet therapy. The initial enrofloxacin injectable administration should be followed 12 hours later by initiation of enrofloxacin tablet therapy.

Enrofloxacin

SPL · SPL

FDA Structured Product Label

Enrofloxacin

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Accord Healthcare, Inc.
ANADA
200-697
Status
RX
Form
Injectable Solution
Route
Intramuscular
Species
Dog, No Use Class Stated Or Implied
Composition / specifications
22.7 mg/mL (2.27%)

Dogs

Indication

For the management of diseases in dogs associated with bacteria susceptible to enrofloxacin.

Dosage

Enrofloxacin Injectable Solution may be used as the initial dose at 2.5 mg/kg. It should be administered intramuscularly (IM) as a single dose, followed by initiation of enrofloxacin tablet therapy. The initial Enrofloxacin Injectable administration should be followed 12 hours later by initiation of enrofloxacin tablet therapy.

Enrofloxacin Flavored Tablets

SPL · SPL

FDA Structured Product Label

Enrofloxacin Flavored Tablets

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Felix Pharmaceuticals Pvt. Ltd.
ANADA
200-680
Status
RX
Form
Flavored Tablets
Route
Oral
Species
Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
22.7 mg, 68 mg, and 136 mg enrofloxacin per tablet

Dogs

Indication

For the management of diseases associated with bacteria susceptible to enrofloxacin.

Dosage

Administer orally at a rate to provide 5-20 mg/kg (2.27 to 9.07 mg/lb) of body weight. May be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals. The dose should be continued for at least 2-3 days beyond cessation of clinical signs to a maximum of 30 days.

Cats

Indication

For the management of diseases associated with bacteria susceptible to enrofloxacin.

Dosage

Administer orally at 5 mg/kg (2.27 mg/lb) of body weight. May be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals. The dose should be continued for at least 2-3 days beyond cessation of clinical signs to a maximum of 30 days.

EnroMed™ 100

SPL · SPL

FDA Structured Product Label

EnroMed™ 100

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Bimeda Animal Health Limited
ANADA
200-598
Status
RX
Form
Injectable Solution
Route
Intramuscular, Subcutaneous, Injection
Species
No use class stated or implied • Beef And Non-Lactating Dairy
Composition / specifications
100 mg/mL

Cattle (beef and non-lactating dairy)

Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non-lactating dairy cattle; and for the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.

Dosage

Single-Dose Therapy (BRD Treatment): Administer, by subcutaneous injection, a single dose of 7.5-12.5 mg/kg of body weight (3.4-5.7 mL/100 lb).

Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni in beef and non-lactating dairy cattle.

Dosage

Multiple-Day Therapy (BRD Treatment): Administer daily, a subcutaneous dose of 2.5-5 mg/kg of body weight (1.1-2.3 mL/100 lb). Treatment should be repeated at 24-hour intervals for three days. Additional treatments may
be given on Days 4 and 5 to animals that have shown clinical improvement but not total recovery.

Swine

Indication

For the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae. and for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed.

Dosage

Administer, either by intramuscular or subcutaneous (behind the ear) injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb). Administered dose volume should not exceed 5 mL per injection site.

Baytril® Soft Chewable Tablets

SPL · SPL

FDA Structured Product Label

Baytril® Soft Chewable Tablets

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Elanco US Inc.
ANADA
200-608
Status
RX
Form
Chewable Tablets
Route
Oral
Species
Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
22.7, 68.0, or 136.0 milligrams (mg) enrofloxacin

Cats

Indication

For the management of diseases associated with bacteria susceptible to enrofloxacin.

Dosage

Administer orally at 5 mg/kg (2.27 mg/lb) of body weight. The dose for dogs and cats may be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals. The dose should be continued for at least 2-3 days beyond cessation of clinical signs, to a maximum of 30 days. All tablet sizes are double scored for accurate dosing.

Limitations

For use in animals only. In rare instances, use of this product in cats has been associated with Retinal Toxicity. Do not exceed 5 mg/kg of body weight per day in cats. Safety in breeding or pregnant cats has not been established. Keep out of reach of children.

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Federal law prohibits the extra label use of this drug in food-producing animals.

Quinolone-class drugs should be used with caution in animals with known or suspected Central Nervous System (CNS) disorders. In such animals, quinolones have, in rare instances, been associated with CNS stimulation which may lead to convulsive seizures.

Dogs

Indication

For the management of diseases associated with bacteria susceptible to enrofloxacin.

Dosage

Administer orally at a rate to provide 5-20 mg/kg (2.27 to 9.07 mg/lb) of body weight. Selection of a dose within the range should be based on clinical experience, the severity of disease, and susceptibility of the pathogen. Animals which receive doses in the upper-end of the dose range should be carefully monitored for clinical signs that may include inappetence, depression, and vomition. All tablet sizes are double scored for accurate dosing.

Limitations

The use of enrofloxacin is contraindicated in small and medium breeds of dogs during the rapid growth phase (between 2 and 8 months of age). The safe use of enrofloxacin has not been established in large and giant breeds of dogs during the rapid growth phase.

For use in animals only. Keep out of reach of children.

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Federal law prohibits the extra label use of this drug in food-producing animals.

Quinolone-class drugs should be used with caution in animals with known or suspected Central Nervous System (CNS) disorders. In such animals, quinolones have, in rare instances, been associated with CNS stimulation which may lead to convulsive seizures.

Enroflox® 100

SPL · SPL

FDA Structured Product Label

Enroflox® 100

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Norbrook Laboratories, Ltd.
ANADA
200-495
Status
RX
Form
Injectable Solution
Route
Intramuscular, Subcutaneous
Species
No use class stated or implied • Beef And Non-Lactating Dairy
Composition / specifications
100 mg/mL

Swine

Indication

Enroflox 100 is indicated for the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis and Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae.

Enroflox 100 is indicated for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed.

Dosage

Administer, either by intramuscular or subcutaneous (behind the ear) injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb). Administered dose volume should not exceed 5 mL per injection site. For the control of colibacillosis, administrations should be initiated within the first 60 days post-weaning when clinical signs are present in at least 2% of the animals in the group.

Limitations

Animals intended for human consumption must not be slaughtered within five days of receiving a single-injection dose.

Cattle (Single- Dose Therapy)

Indication

Enroflox 100 is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non-lactating dairy cattle.

Dosage
Administer, by subcutaneous injection, a single dose of 7.5-12.5 mg/kg of body weight (3.4-5.7 mL/100 lb).
Limitations

Animals intended for human consumption must not be slaughtered within 28 days from the last treatment. This product is not approved for female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

Indication

Enroflox 100 is indicated for the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.

Dosage
Administer, by subcutaneous injection, a single dose of 7.5 mg/kg of body weight (3.4 ml/100 lb).
Limitations

Animals intended for human consumption must not be slaughtered within 28 days from the last treatment. This product is not approved for female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

Cattle (Multiple Day Therapy)

Indication
Enroflox 100 is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni in beef an non-lactating dairy cattle.
Dosage

Administer daily, a subcutaneous dose of 2.5-5 mg/kg of body weight (1.1-2.3 mL/100 lb). Treatment should be repeated at 24-hour intervals for three days. Additional treatments may be given on Days 4 and 5 to animals that have shown clinical improvement but not total recovery.

Limitations

Animals intended for human consumption must not be slaughtered within 28 days from the last treatment. This product is not approved for female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

Enrofloxacin Antibacterial Injectable Solution

SPL · SPL

FDA Structured Product Label

Enrofloxacin Antibacterial Injectable Solution

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Dechra Veterinary Products LLC
ANADA
200-527
Status
RX
Form
Injectable Solution
Route
Intramuscular
Species
Dog, No Use Class Stated Or Implied
Composition / specifications
22.7 mg/mL enrofloxacin

Label highlights

Indication
For the management of diseases in dogs associated with bacteria susceptible to enrofloxacin
Dosage
Administer 2.5 mg/kg as a single dose, followed by initiation of enrofloxacin tablet therapy
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian

Enrofloxacin Flavored Tablets

SPL · SPL

FDA Structured Product Label

Enrofloxacin Flavored Tablets

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Dechra Veterinary Products LLC
ANADA
200-551
Status
RX
Form
Tablet
Route
Oral
Species
Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
Each tablet contains 22.7, 68, or 136 mg of enrofloxacin.

<strong>Dogs</strong>

Indication
For the management of diseases associated with bacteria susceptible to enrofloxacin
Dosage
Administer orally at a rate to provide 5-20 mg/kg (2.27-9.07 mg/lb) of body weight as a single, daily dose, or divided into two equal doses at 12-hour intervals.

Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals

<strong>Cats</strong>

Indication
For the management of diseases associated with bacteria susceptible to enrofloxacin
Dosage
Administer orally at a rate to provide 5 mg/kg (2.27 mg/lb) of body weight as a single, daily dose, or divided into two equal doses at 12-hour intervals
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals

Enroflox™ Injection for Dogs 2.27%

SPL · SPL

FDA Structured Product Label

Enroflox™ Injection for Dogs 2.27%

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Norbrook Laboratories, Ltd.
ANADA
200-513
Status
RX
Form
Injectable Solution
Route
Intramuscular
Species
Dog, No Use Class Stated Or Implied
Composition / specifications
22.7 mg/mL

Dogs

Indication
For the management of diseases in dogs associated with bacteria susceptible to enrofloxacin.
Dosage
Administer intramuscularly (IM) as a single injection at the rate of 1 mL/9.1 kg (20 lb) to provide 2.5 mg/kg (1.13 mg/lb). The injectable dose should be followed by oral tablet treatment in 12 hours.

Zobuxa™

SPL · SPL

FDA Structured Product Label

Zobuxa™

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Elanco US Inc.
ANADA
200-517
Status
RX
Form
Tablet
Route
Oral
Species
Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
22.7 mg, 68 mg, 136 mg, and 272 mg

<strong>Dogs</strong>

Indication
For the management of diseases associated with bacteria susceptible to enrofloxacin
Dosage
Administer orally at a rate to provide 5-20 mg/kg (2.27 to 9.07 mg/lb) of body weight. Selection of a dose within the range should be based on clinical experience, the severity of disease, and susceptibility of the pathogen. Animals which receive doses in the upper-end of the dose range should be carefully monitored for clinical signs that may include inappetence, depression, and vomition
Limitations
Federal law restricts this drug to use by or on the order of licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals

<strong>Cats</strong>

Indication
For the management of diseases associated with bacteria susceptible to enrofloxacin
Dosage
Administer orally at 5 mg/kg (2.27 mg/lb) of body weight. The dose for dogs and cats may be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals. The doses should be continued for at least 2-3 days beyond cessation of clinical signs, to a maximum of 30 days
Limitations
Federal law restricts this drug to use by or on the order of licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals

Enrofloxacin SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Enrofloxacin. Use the source link for the full official labeling record.

Enrofloxacin Base SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Enrofloxacin Base. Use the source link for the full official labeling record.

Enrofloxacin HCl SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Enrofloxacin HCl. Use the source link for the full official labeling record.

ENROFLOXACIN SPL

SPL · Structured Product Label

FDA Structured Product Label XML for ENROFLOXACIN. Use the source link for the full official labeling record.

ENROFLOXACIN SPL

SPL · Structured Product Label

FDA Structured Product Label XML for ENROFLOXACIN. Use the source link for the full official labeling record.

SolutionKits Enrofloxacin SPL

SPL · Structured Product Label

FDA Structured Product Label XML for SolutionKits Enrofloxacin. Use the source link for the full official labeling record.

Enrosite Flavored SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Enrosite Flavored. Use the source link for the full official labeling record.

Baytril SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Baytril. Use the source link for the full official labeling record.

Enrofloxacin SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Enrofloxacin. Use the source link for the full official labeling record.

Baytril SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Baytril. Use the source link for the full official labeling record.

Enroflox SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Enroflox. Use the source link for the full official labeling record.

Enrofloxacin 100 SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Enrofloxacin 100. Use the source link for the full official labeling record.

Enrofloxacin Flavored SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Enrofloxacin Flavored. Use the source link for the full official labeling record.

Enrosite SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Enrosite. Use the source link for the full official labeling record.

Enroflox SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Enroflox. Use the source link for the full official labeling record.

Enrofloxacin SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Enrofloxacin. Use the source link for the full official labeling record.

Enroquin Flavored SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Enroquin Flavored. Use the source link for the full official labeling record.

Enroquin SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Enroquin. Use the source link for the full official labeling record.

Enrofloxacin Flavored SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Enrofloxacin Flavored. Use the source link for the full official labeling record.

EnroPro 100 SPL

SPL · Structured Product Label

FDA Structured Product Label XML for EnroPro 100. Use the source link for the full official labeling record.

Enrofloxacin SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Enrofloxacin. Use the source link for the full official labeling record.

Enroflox 100 SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Enroflox 100. Use the source link for the full official labeling record.

Enrofloxacin SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Enrofloxacin. Use the source link for the full official labeling record.

Tenotryl SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Tenotryl. Use the source link for the full official labeling record.

EnroPro 22.7 SPL

SPL · Structured Product Label

FDA Structured Product Label XML for EnroPro 22.7. Use the source link for the full official labeling record.

Enrosite SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Enrosite. Use the source link for the full official labeling record.

Fluroxin for Dogs 2.27% SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Fluroxin for Dogs 2.27%. Use the source link for the full official labeling record.

Fluroxin Flavored SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Fluroxin Flavored. Use the source link for the full official labeling record.

Baytril SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Baytril. Use the source link for the full official labeling record.

Baytril SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Baytril. Use the source link for the full official labeling record.

EnroMed SPL

SPL · Structured Product Label

FDA Structured Product Label XML for EnroMed. Use the source link for the full official labeling record.

Quellaxcin SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Quellaxcin. Use the source link for the full official labeling record.

Enrofloxacin SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Enrofloxacin. Use the source link for the full official labeling record.

AX Pharmaceutical Corp SPL

SPL · Structured Product Label

FDA Structured Product Label XML for AX Pharmaceutical Corp. Use the source link for the full official labeling record.

ENROFLOXACIN SPL

SPL · Structured Product Label

FDA Structured Product Label XML for ENROFLOXACIN. Use the source link for the full official labeling record.

X SPL

SPL · Structured Product Label

FDA Structured Product Label XML for X. Use the source link for the full official labeling record.

ENROFLOXACIN SPL

SPL · Structured Product Label

FDA Structured Product Label XML for ENROFLOXACIN. Use the source link for the full official labeling record.

Enrofloxacin SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Enrofloxacin. Use the source link for the full official labeling record.

AX Pharmaceutical Corp SPL

SPL · Structured Product Label

FDA Structured Product Label XML for AX Pharmaceutical Corp. Use the source link for the full official labeling record.

Enrofloxacin 100 SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Enrofloxacin 100. Use the source link for the full official labeling record.

Enroflox 100 SPL

SPL · Structured Product Label

FDA Structured Product Label XML for Enroflox 100. Use the source link for the full official labeling record.

UCM433789.pdf

FOI · FOI

UCM338202.pdf

FOI · FOI

UCM322234.pdf

FOI · FOI

UCM256760.pdf

FOI · FOI

ucm116772.pdf

FOI · FOI

ucm116769.pdf

FOI · FOI

N141068_Orig_07_24_1998.pdf

FOI · FOI

UCM326939.pdf

FOI · FOI

ucm062414.pdf

FOI · FOI

UCM062413.pdf

FOI · FOI

N140441_Supp_6_6_1990.pdf

FOI · FOI

UCM327831.pdf

FOI · FOI

N140441_Orig_12_27_1988.pdf

FOI · FOI

ucm115727.pdf

FOI · FOI

N140913_Orig_5_4_1990.pdf

FOI · FOI

FOI Summary oA 200-810 Approved March 24, 2025.pdf

FOI · FOI

FOI Summary oA 200-765 Approved December 22, 2023.pdf

FOI · FOI

FOI Summary oA 200-764 Approved December 22, 2023.pdf

FOI · FOI

FOI Summary oA 200-758 Approved November 8, 2023.pdf

FOI · FOI

N-141527-Q-0003-OT-AA_foi.pdf

FOI · FOI

FOI Summary oA 200-737 Approved February 2, 2023.pdf

FOI · FOI

FOI Summary oA 200-720 Approved March 11, 2022.pdf

FOI · FOI

FOI Summary oA 200-688 Approved March 28, 2022.pdf

FOI · FOI

FOI Summary oA 200-628 Approved October 29, 2021.pdf

FOI · FOI

FOI Summary oA 200-708 Approved August 2, 2021.pdf

FOI · FOI

FOI Summary oA 200-697 Approved April 5, 2021.pdf

FOI · FOI

A-200680-Q-0001-OT-AA_foi.pdf

FOI · FOI

FOI Summary oA 200-598 Approved May 16, 2019.pdf

FOI · FOI

FOI Summary oA 200-608 Approved July 30, 2018.pdf

FOI · FOI

FOI Summary sA 200-495 Approved July 6, 2018.pdf

FOI · FOI

UCM457232.pdf

FOI · FOI

UCM351212.pdf

FOI · FOI

UCM433787.pdf

FOI · FOI

UCM355452.pdf

FOI · FOI

UCM408900.pdf

FOI · FOI

UCM367491.pdf

FOI · FOI

ucm117262.pdf

FOI · FOI summary

FOI Summary oA 200-782 Approved May 9, 2024.pdf

FOI · FOI summary

Veterinary reference (advanced)

Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness
  • Storefront facts: Source Roxee | Refreshed May 5, 2026, 10:00 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Apr 10, 2026, 10:01 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed May 5, 2026, 10:00 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: AX Pharmaceutical Corp Baytril ENROFLOXACIN EnroMed EnroPro 100 EnroPro 22.7 Enroflox Enroflox 100 Enrofloxacin Enrofloxacin 100 Enrofloxacin Base Enrofloxacin Flavored Enrofloxacin HCl Enroquin Enroquin Flavored Enrosite Enrosite Flavored Fluroxin Flavored Fluroxin for Dogs 2.27% Quellaxcin SolutionKits Enrofloxacin Tenotryl X
Manufacturer mapping: Multiple FDA labelers
Case-reported brands (openFDA): MSK
Catalog species: Both FDA-labeled species: Beef, Beef And Non-Lactating Dairy, Cat, Dairy, Dog, No use class stated or implied, Replacement dairy heifers under 20 months of age
Rx/OTC: RX
Form/route: Chewable Tablets, Flavored Tablets, Injectable Solution, Liquid (Solution), Solution, Tablet Injection, Intramuscular, Oral, Subcutaneous
Applications: NADA 141-068 • NADA 140-441 • NADA 140-913 • ANADA 200-810 • ANADA 200-765 • ANADA 200-764 • ANADA 200-758 • NADA 141-527 • ANADA 200-737 • ANADA 200-720 • ANADA 200-688 • ANADA 200-628 • ANADA 200-708 • ANADA 200-697 • ANADA 200-680 • ANADA 200-598 • ANADA 200-608 • ANADA 200-495 • ANADA 200-527 • ANADA 200-551 • ANADA 200-513 • ANADA 200-517
NDC: Packages 11695-6954-1 11695-6954-5 11695-6955-2 11695-6955-5 11695-6956-2 11695-6956-5 Products 11695 13985 17033 43457 46066 46144
Documents: 38 (FOI: 36) • SPL: 23 Label highlights Official documents
Safety (openFDA)
Top reactions: Dog 64 Cat 60 View
Case summaries: 9 (showing 8) View
openFDA reports are unverified and do not prove causation.

Explore
Linked using: Fda_Label (0.95), Fda_Label (0.95), Fda_Label (0.95)

Diagnosis Codes
ICD10_CM: H60.90
Otitis externa, unspecified ear

Counseling and Monitoring Highlights

Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.

Owner-facing counseling points
  • Use caution in young/growing animals (joint/cartilage risk). Avoid in pets with known fluoroquinolone sensitivity. (Contraindication, High)
Top reaction signals
Crust (1) Cough (1) Confusion (1) Claw / hoof / nail disorder NOS (1) Circling - behavioural disorder (1) Cholangiohepatitis (1) Cellulitis (1) CARBON DIOXIDE LOW, BLOOD (1)

Identifiers & Packages

Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.

Identifiers
ANADA: 200495 ANADA: 200513 ANADA: 200517 ANADA: 200527 ANADA: 200551 ANADA: 200598 ANADA: 200608 ANADA: 200628 ANADA: 200680 ANADA: 200688 ANADA: 200697 ANADA: 200708 ANADA: 200720 ANADA: 200737 ANADA: 200758 ANADA: 200764 ANADA: 200765 ANADA: 200782 ANADA: 200810 NADA: 140441 NADA: 140913 NADA: 141068 NADA: 141176 NADA: 141527
Package NDC Product NDC Form / Route Status
11695-6954-1 11695 -
11695-6954-5 11695 -
11695-6955-2 11695 -
11695-6955-5 11695 -
11695-6956-2 11695 -
11695-6956-5 11695 -
11695-6999-1 11695 -
11695-7022-1 11695 -
11695-7022-2 11695 -
11695-7035-1 11695 -
11695-7035-2 11695 -
13985-709-20 13985 -
13985-709-50 13985 -
13985-978-05 13985 -
13985-978-10 13985 -
13985-979-25 13985 -
13985-979-50 13985 -
13985-980-20 13985 -
13985-980-50 13985 -
17033-303-10 17033 -

Enriched Documents

Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.

  • Enrofloxacin SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Enrofloxacin Base SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Enrofloxacin HCl SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • ENROFLOXACIN SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • ENROFLOXACIN SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • SolutionKits Enrofloxacin SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Enrosite Flavored SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Baytril SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Enrofloxacin SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Baytril SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Enroflox SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Enrofloxacin 100 SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Enrofloxacin Flavored SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Enrosite SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Enroflox SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Enrofloxacin SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Enroquin Flavored SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Enroquin SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Enrofloxacin Flavored SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • EnroPro 100 SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Enrofloxacin SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Enroflox 100 SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Enrofloxacin SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Tenotryl SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • EnroPro 22.7 SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Enrosite SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Fluroxin for Dogs 2.27% SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Fluroxin Flavored SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Baytril SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Baytril SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • EnroMed SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Quellaxcin SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Enrofloxacin SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • AX Pharmaceutical Corp SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • ENROFLOXACIN SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • X SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • ENROFLOXACIN SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Enrofloxacin SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • AX Pharmaceutical Corp SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Enrofloxacin 100 SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.

Data Sources & Change Log

Every non-trivial field is expected to include provenance and update timestamps.

Official 114 Clinical 7 Manufacturer 0 Marketing 0

Marketing/Manufacturer content exists: 1 linked manufacturer ad video are attached to this medication.

Current Field Facts
  • overdose_info: Overdose may exacerbate GI and neurologic signs; in cats, high doses increase the risk of irreversible blindness. Supportive care is required. (Clinical, 2026-04-12)
  • overdose_info: Overdose may exacerbate GI and neurologic signs; in cats, high doses increase the risk of irreversible blindness. Supportive care is required. (Clinical, 2026-04-11)
  • overdose_info: Overdose may exacerbate GI and neurologic signs; in cats, high doses increase the risk of irreversible blindness. Supportive care is required. (Clinical, 2026-02-12)
  • side_effects: GI upset. In cats, high doses can cause retinal toxicity and vision loss. (Clinical, 2026-04-11)
  • storage_handling: Store at room temperature away from moisture. (Clinical, 2026-04-12)
  • storage_handling: Store at room temperature away from moisture. (Clinical, 2026-04-11)
  • storage_handling: Store at room temperature away from moisture. (Clinical, 2026-02-12)
  • contraindications: Use caution in young/growing animals (joint/cartilage risk). Avoid in pets with known fluoroquinolone sensitivity. (Official, 2026-04-12)
  • contraindications: Use caution in young/growing animals (joint/cartilage risk). Avoid in pets with known fluoroquinolone sensitivity. (Official, 2026-04-11)
  • contraindications: Use caution in young/growing animals (joint/cartilage risk). Avoid in pets with known fluoroquinolone sensitivity. (Official, 2026-02-12)
  • indications: Baytril (brand of enrofloxacin) Antibacterial Tablets and Injectable Solution are indicated for the treatment of the following bacterial infections in dogs: De… (Official, 2026-05-05)
  • indications: Baytril (brand of enrofloxacin) Antibacterial Tablets and Injectable Solution are indicated for the treatment of the following bacterial infections in dogs: De… (Official, 2026-05-03)
  • indications: Baytril (brand of enrofloxacin) Antibacterial Tablets and Injectable Solution are indicated for the treatment of the following bacterial infections in dogs: De… (Official, 2026-05-02)
  • indications: Baytril (brand of enrofloxacin) Antibacterial Tablets and Injectable Solution are indicated for the treatment of the following bacterial infections in dogs: De… (Official, 2026-04-29)
  • indications: Baytril (brand of enrofloxacin) Antibacterial Tablets and Injectable Solution are indicated for the treatment of the following bacterial infections in dogs: De… (Official, 2026-04-28)
  • indications: Baytril (brand of enrofloxacin) Antibacterial Tablets and Injectable Solution are indicated for the treatment of the following bacterial infections in dogs: De… (Official, 2026-04-27)
  • indications: Baytril (brand of enrofloxacin) Antibacterial Tablets and Injectable Solution are indicated for the treatment of the following bacterial infections in dogs: De… (Official, 2026-04-26)
  • indications: Baytril (brand of enrofloxacin) Antibacterial Tablets and Injectable Solution are indicated for the treatment of the following bacterial infections in dogs: De… (Official, 2026-04-25)
  • indications: Baytril (brand of enrofloxacin) Antibacterial Tablets and Injectable Solution are indicated for the treatment of the following bacterial infections in dogs: De… (Official, 2026-04-22)
  • manufacturer_name: Multiple FDA labelers (Official, 2026-05-05)
Recent Revisions
  • side_effects updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-02-12 19:40 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-02-12 19:40 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-02-12 19:40 by etl_backfill • Backfilled from existing medication fields

FDA Products & Applications (Animal Drugs @ FDA)

Official sponsor/proprietary-name/application-status records linked by active ingredient.

Product Sponsor Application Status Published
Baytril™ 100
RX
Enrofloxacin
Solution Intramuscular, Subcutaneous
Elanco US Inc. NADA 141-068 Approved Apr 9, 2026
Baytril™ Antibacterial Tablets Baytril™ Taste Tabs™ Antibacterial Tablets
RX
Enrofloxacin
Tablet Oral
Elanco US Inc. NADA 140-441 Approved Apr 6, 2026
Baytril™ Antibacterial Injectable Solution
RX
Enrofloxacin
Liquid (Solution) Intramuscular
Elanco US Inc. NADA 140-913 Approved Apr 1, 2026
Enrofloxacin Flavored Tablets
RX
Enrofloxacin
Flavored Tablets Oral
Hikma Pharmaceuticals USA, Inc. ANADA 200-810 Approved Mar 28, 2025
EnroPro™ 100
RX
Enrofloxacin
Injectable Solution Intramuscular, Subcutaneous
Cronus Pharma Specialities India Private Ltd. ANADA 200-765 Approved Jan 2, 2024
EnroPro™ 22.7
RX
Enrofloxacin
Injectable Solution Intramuscular
Cronus Pharma Specialities India Private Ltd. ANADA 200-764 Approved Jan 2, 2024
Enrofloxacin
RX
Enrofloxacin
Injectable Solution Intramuscular, Subcutaneous
Felix Pharmaceuticals Pvt. Ltd. ANADA 200-758 Approved Nov 28, 2023
Baytril® 100-CA1
RX
Enrofloxacin
Injectable Solution Subcutaneous
Elanco US Inc. NADA 141-527 W May 3, 2023
Enrofloxacin
RX
Enrofloxacin
Flavored Tablets Oral
ZYVET AH, Inc. ANADA 200-737 Approved Mar 1, 2023
Enroflox® Chewable Tablets
RX
Enrofloxacin
Chewable Tablets Oral
Norbrook Laboratories, Ltd. ANADA 200-720 Approved Apr 1, 2022
Tenotryl™
RX
Enrofloxacin
Injectable Solution Intramuscular, Subcutaneous
Virbac AH, Inc. ANADA 200-688 Approved Apr 1, 2022
ENROFLOXACIN 100
RX
Enrofloxacin
Injectable Solution Subcutaneous, Intramuscular
Sparhawk Laboratories, Inc. ANADA 200-628 Approved Nov 1, 2021
Enrofloxacin
RX
Enrofloxacin
Injectable Solution Intramuscular
Felix Pharmaceuticals Pvt. Ltd. ANADA 200-708 Approved Sep 1, 2021
Enrofloxacin
RX
Enrofloxacin
Injectable Solution Intramuscular
Accord Healthcare, Inc. ANADA 200-697 Approved May 3, 2021
Enrofloxacin Flavored Tablets
RX
Enrofloxacin
Flavored Tablets Oral
Felix Pharmaceuticals Pvt. Ltd. ANADA 200-680 Approved Jun 17, 2020
EnroMed™ 100
RX
Enrofloxacin
Injectable Solution Intramuscular, Subcutaneous, Injection
Bimeda Animal Health Limited ANADA 200-598 Approved Jun 3, 2019
Baytril® Soft Chewable Tablets
RX
Enrofloxacin
Chewable Tablets Oral
Elanco US Inc. ANADA 200-608 Approved Aug 29, 2018
Enroflox® 100
RX
Enrofloxacin
Injectable Solution Intramuscular, Subcutaneous
Norbrook Laboratories, Ltd. ANADA 200-495 Approved Aug 2, 2018
Enrofloxacin Antibacterial Injectable Solution
RX
Enrofloxacin
Injectable Solution Intramuscular
Dechra Veterinary Products LLC ANADA 200-527 Approved Jun 1, 2016
Enrofloxacin Flavored Tablets
RX
Enrofloxacin
Tablet Oral
Dechra Veterinary Products LLC ANADA 200-551 Approved Jun 1, 2016
Enroflox™ Injection for Dogs 2.27%
RX
Enrofloxacin
Injectable Solution Intramuscular
Norbrook Laboratories, Ltd. ANADA 200-513 Approved Jun 1, 2016
Zobuxa™
RX
Enrofloxacin
Tablet Oral
Elanco US Inc. ANADA 200-517 Approved Jun 1, 2016

Data source: FDA Animal Drugs @ FDA (public search export).

What It's For (FDA Label Highlights)

Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.

Species: No use class stated or implied • Beef, excluding veal calves • Dairy, females Under 20 months of age
Composition / specifications
Each mL of sterile solution contains 100 mg of enrofloxacin.
Swine
Indication
For the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed
Dosage
Administer, either by intramuscular or subcutaneous (behind the ear) injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb). For the control of colibacillosis, administration should be initiated within the first 60 days post-weaning when clinical signs are present in at least 2% of the animals in the group. If no improvement is noted within 48 hours, the diagnosis should be reevaluated.
Limitations
Indication
For the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae.
Dosage
Administer, either by intramuscular or subcutaneous (behind the ear) injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb).
Limitations
Cattle (Beef and Non-Lactating Dairy)
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beef and non-lactating dairy cattle

Dosage

Multiple-day therapy: 2.5 to 5.0 mg/kg of body weight (1.1 to 2.3 mL/100 lb) by subcutaneous injection. Treatment should be repeated at 24-hour intervals for three days. Additional treatments may be given on Days 4 and 5 to animals that have shown clinical improvement but not total recovery. Administered dose volume should not exceed 20 mL per injection site.

Limitations
Indication
For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni, and Mycoplasma bovis in beef and non-lactating dairy cattle
Dosage

Single-dose therapy: 7.5 to 12.5 mg/kg of body weight (3.4 to 5.7 mL/100 lb) by subcutaneous injection. Administered dose volume should not exceed 20 mL per injection site.

Limitations
Indication

For the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis

Dosage

Single-dose therapy: 7.5 mg/kg of body weight (3.4 mL/100 lb) by subcutaneous injection. Administered dose volume should not exceed 20 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
Each tablet contains either 22.7, 68.0, or 136 milligrams of enrofloxacin.
Cats
Indication
For management of diseases associated with bacteria susceptible to enrofloxacin.
Dosage
5 milligrams per kilogram (2.27 milligrams per pound) of body weight.
Limitations
Dogs
Indication
For management of diseases associated with bacteria susceptible to enrofloxacin.
Dosage
5 to 20 milligrams per kilogram (2.27 to 9.07 milligrams per pound) of body weight.
Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
Each milliliter of sterile aqueous solution contains 22.7 milligrams of enrofloxacin.
Dogs
Indication
Dogs for management of diseases associated with bacteria susceptible to enrofloxacin.
Dosage
2.5 milligrams intramuscularly per kilogram (1.13 milligrams per pound) of body weight as a single initial dose only.
Limitations

As a single, intramuscular, initial dose followed by use of tablets twice daily for 2 to 3 days beyond cessation of clinical signs to a maximum of 30 days.

FDA page: Open in Animal Drugs @ FDA

Composition / specifications
22.7 mg, 68 mg, or 136 mg of enrofloxacin per tablet
Dogs
Indication

For the management of diseases associated with bacteria susceptible to enrofloxacin

Dosage

Administer orally at 5 to 20 milligrams per kilogram (2.27 to 9.07 milligrams per pound) of body weight. The dose may be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals.

Limitations
Cats
Indication

For the management of diseases associated with bacteria susceptible to enrofloxacin

Dosage

Administer orally at 5 milligrams per kilogram (2.27 milligrams per pound) of body weight. The dose may be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied • Beef And Non-Lactating Dairy
Composition / specifications
100 mg/mL
Cattle (Beef and Non-Lactating Dairy)
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beef and non-lactating dairy cattle.

Dosage

Multiple-day therapy: 2.5 to 5.0 mg/kg of body weight (1.1 to 2.3 mL/100 lb) by subcutaneous injection. Treatment should be repeated at 24-hour intervals for three days. Additional treatments may be given on Days 4 and 5 to animals that have shown clinical improvement but not total recovery. Administered dose volume should not exceed 20 mL per injection site.

Limitations
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni, and Mycoplasma bovis in beef and non-lactating dairy cattle.

Dosage

Single-dose therapy: 7.5 to 12.5 mg/kg of body weight (3.4 to 5.7 mL/100 lb) by subcutaneous injection. Administered dose volume should not exceed 20 mL per injection site.

Limitations
Indication

For the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.

Dosage

Single-dose therapy: 7.5 mg/kg of body weight (3.4 mL/100 lb) by subcutaneous injection. Administered dose volume should not exceed 20 mL per injection site.

Limitations
Swine
Indication

For the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae.

Dosage

Administer, either by intramuscular or subcutaneous (behind the ear) injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb).

Limitations
Indication

For the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed

Dosage

Administer, either by intramuscular or subcutaneous (behind the ear) injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb). For the control of colibacillosis, administration should be initiated within the first 60 days post-weaning when clinical signs are present in at least 2% of the animals in the group. If no improvement is noted within 48 hours, the diagnosis should be reevaluated.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
22.7 mg/mL (2.27%)
Dogs
Indication

For the management of diseases in dogs associated with bacteria susceptible to enrofloxacin.

Dosage

2.5 milligrams intramuscularly per kilogram (1.13 milligrams per pound) of body weight as a single initial dose only.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied • Beef And Non-Lactating Dairy
Composition / specifications
100 mg/mL
Cattle (Beef and Non-Lactating Dairy)
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non-lactating dairy cattle

Dosage

Single-Dose Therapy (BRD Treatment): Administer, by subcutaneous injection, a single dose of 7.5 – 12.5 mg/kg of body weight (3.4 – 5.7 mL/100 lb).

Limitations
Indication

For the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.

Dosage

Single-Dose Therapy (BRD Control): Administer, by subcutaneous injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb).

Limitations
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni in beef and non-lactating dairy cattle.

Dosage

Multiple-Day Therapy (BRD Treatment): Administer daily, a subcutaneous dose of 2.5 – 5 mg/kg of body weight (1.1 – 2.3 mL/100 lb). Treatment should be repeated at 24-hour intervals for three days. Additional treatments may be given on Days 4 and 5 to animals that have shown clinical improvement but not total recovery.

Limitations
Swine
Indication

For the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae; and for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed.

Dosage

Administer, either by intramuscular or subcutaneous (behind the ear) injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb). Administered dose volume should not exceed 5 mL per injection site. For the control of colibacillosis, administration should be initiated within the first 60 days post-weaning when clinical signs are present in at least 2% of the animals in the group.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Replacement dairy heifers under 20 months of age • Beef, except beef calves less than 2 months of age and beef bulls intended for breeding (any age)
Composition / specifications
100 mg/mL
Cattle (replacement dairy heifers under 20 months of age and all classes of beef cattle except beef calves less than 2 months of age and beef bulls intended for breeding (any age))
Indication

Conditionally approved for the treatment of clinical anaplasmosis associated with Anaplasma marginale in replacement dairy heifers under 20 months of age and all classes of beef cattle except beef calves less than 2 months of age and beef bulls intended for breeding (any age). Not for use in any other class of dairy cattle or in veal calves.

Dosage

Administer as a single dose for treatment of clinical anaplasmosis. Administer, by subcutaneous injection, a single dose of 12.5 mg/kg of body weight (5.7 mL/100 lb). Administered dose volume should not exceed 20 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
22.7 mg, 68 mg, or 136 mg of enrofloxacin per tablet
Dogs
Indication

For the management of diseases associated with bacteria susceptible to enrofloxacin

Dosage

Administer orally at a rate to provide 5-20 mg/kg (2.27 to 9.07 mg/lb) of body weight. The dose may be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals. Selection of a dose within the range should be based on clinical experience, the severity of disease, and susceptibility of the pathogen. Animals which receive doses in the upper-end of the dose range should be carefully monitored for clinical signs that may include inappetence, depression, and vomition.

Limitations
Cats
Indication

For the management of diseases associated with bacteria susceptible to enrofloxacin

Dosage

Administer orally at 5 mg/kg (2.27 mg/lb) of body weight. The dose may be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals. The dose should be continued for at least 2-3 days beyond cessation of clinical signs, to a maximum of 30 days.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
22.7 mg, 68 mg, or 136 mg of enrofloxacin per tablet
Dogs
Indication

For the management of diseases associated with bacteria susceptible to enrofloxacin.

Dosage

Administer orally at a rate to provide 5-20 mg/kg (2.27 to 9.07 mg/lb) of body weight as a single daily dose or divided into two (2) equal daily doses at twelve (12) hour intervals.

Limitations
Cats
Indication

For the management of diseases associated with bacteria susceptible to enrofloxacin.

Dosage

Administer orally at 5 mg/kg (2.27 mg/lb) of body weight as a single daily dose or divided into two (2) equal daily doses at twelve (12) hour intervals.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied • Beef And Non-Lactating Dairy
Composition / specifications
100 mg/mL
Beef cattle and non-lactating dairy cattle
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non-lactating dairy cattle.

Dosage

Administer, by subcutaneous injection, a single dose of 7.5 – 12.5 mg/kg of body weight (3.4 – 5.7 mL/100 lb).

Limitations
Indication

For the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.

Dosage

Administer, by subcutaneous injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb). Administered dose volume should not exceed 20 mL per injection site.

Limitations
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni in beef and non-lactating dairy cattle.

Dosage

Administer daily, a subcutaneous dose of 2.5 – 5 mg/kg of body weight (1.1 – 2.3 mL/100 lb). Treatment should be repeated at 24-hour intervals for three days. Additional treatments may be given on Days 4 and 5 to animals that have shown clinical improvement but not total recovery.

Limitations
Swine
Indication

For the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae. It is also indicated for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed.

Dosage

Administer, either by intramuscular or subcutaneous (behind the ear) injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb). Administered dose volume should not exceed 5 mL per injection site. For the control of colibacillosis, administration should be initiated within the first 60 days post-weaning when clinical signs are present in at least 2% of the animals in the group.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied • Beef And Non-Lactating Dairy
Composition / specifications
100 mg/mL
Beef cattle, non-lactating dairy cattle
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non-lactating dairy cattle; and for the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.

Dosage

Administer, by subcutaneous injection, a single dose of 7.5-12.5 mg/kg of body weight (3.4-5.7 mL/100 lb).

Limitations
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni in beef and non-lactating dairy cattle.

Dosage

Administer daily, a subcutaneous dose of 2.5-5 mg/kg of body weight (1.1-2.3 mL/100 lb). Treatment should be repeated at 24-hour intervals for three days. Additional treatments may be given on Days 4 and 5 to animals that have shown clinical improvement but not total recovery.

Limitations
Swine
Indication

For the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae. It is also indicated for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed.

Dosage

Administer, either by intramuscular or subcutaneous (behind the ear) injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb). Administered dose volume should not exceed 5 mL per injection site. For the control of colibacillosis, administration should be initiated within the first 60 days post-weaning when clinical signs are present in at least 2% of the animals in the group.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
22.7 mg/mL (2.27%)
Dogs
Indication

For the management of diseases in dogs associated with bacteria susceptible to enrofloxacin.

Dosage

Enrofloxacin Injectable Solution may be used as the initial dose at 2.5 mg/kg. It should be administered intramuscularly (IM) as a single dose, followed by initiation of enrofloxacin tablet therapy. The initial enrofloxacin injectable administration should be followed 12 hours later by initiation of enrofloxacin tablet therapy.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
22.7 mg/mL (2.27%)
Dogs
Indication

For the management of diseases in dogs associated with bacteria susceptible to enrofloxacin.

Dosage

Enrofloxacin Injectable Solution may be used as the initial dose at 2.5 mg/kg. It should be administered intramuscularly (IM) as a single dose, followed by initiation of enrofloxacin tablet therapy. The initial Enrofloxacin Injectable administration should be followed 12 hours later by initiation of enrofloxacin tablet therapy.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
22.7 mg, 68 mg, and 136 mg enrofloxacin per tablet
Dogs
Indication

For the management of diseases associated with bacteria susceptible to enrofloxacin.

Dosage

Administer orally at a rate to provide 5-20 mg/kg (2.27 to 9.07 mg/lb) of body weight. May be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals. The dose should be continued for at least 2-3 days beyond cessation of clinical signs to a maximum of 30 days.

Limitations
Cats
Indication

For the management of diseases associated with bacteria susceptible to enrofloxacin.

Dosage

Administer orally at 5 mg/kg (2.27 mg/lb) of body weight. May be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals. The dose should be continued for at least 2-3 days beyond cessation of clinical signs to a maximum of 30 days.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied • Beef And Non-Lactating Dairy
Composition / specifications
100 mg/mL
Cattle (beef and non-lactating dairy)
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non-lactating dairy cattle; and for the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.

Dosage

Single-Dose Therapy (BRD Treatment): Administer, by subcutaneous injection, a single dose of 7.5-12.5 mg/kg of body weight (3.4-5.7 mL/100 lb).

Limitations
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni in beef and non-lactating dairy cattle.

Dosage

Multiple-Day Therapy (BRD Treatment): Administer daily, a subcutaneous dose of 2.5-5 mg/kg of body weight (1.1-2.3 mL/100 lb). Treatment should be repeated at 24-hour intervals for three days. Additional treatments may
be given on Days 4 and 5 to animals that have shown clinical improvement but not total recovery.

Limitations
Swine
Indication

For the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae. and for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed.

Dosage

Administer, either by intramuscular or subcutaneous (behind the ear) injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb). Administered dose volume should not exceed 5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
22.7, 68.0, or 136.0 milligrams (mg) enrofloxacin
Cats
Indication

For the management of diseases associated with bacteria susceptible to enrofloxacin.

Dosage

Administer orally at 5 mg/kg (2.27 mg/lb) of body weight. The dose for dogs and cats may be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals. The dose should be continued for at least 2-3 days beyond cessation of clinical signs, to a maximum of 30 days. All tablet sizes are double scored for accurate dosing.

Limitations

For use in animals only. In rare instances, use of this product in cats has been associated with Retinal Toxicity. Do not exceed 5 mg/kg of body weight per day in cats. Safety in breeding or pregnant cats has not been established. Keep out of reach of children.

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Federal law prohibits the extra label use of this drug in food-producing animals.

Quinolone-class drugs should be used with caution in animals with known or suspected Central Nervous System (CNS) disorders. In such animals, quinolones have, in rare instances, been associated with CNS stimulation which may lead to convulsive seizures.

Dogs
Indication

For the management of diseases associated with bacteria susceptible to enrofloxacin.

Dosage

Administer orally at a rate to provide 5-20 mg/kg (2.27 to 9.07 mg/lb) of body weight. Selection of a dose within the range should be based on clinical experience, the severity of disease, and susceptibility of the pathogen. Animals which receive doses in the upper-end of the dose range should be carefully monitored for clinical signs that may include inappetence, depression, and vomition. All tablet sizes are double scored for accurate dosing.

Limitations

The use of enrofloxacin is contraindicated in small and medium breeds of dogs during the rapid growth phase (between 2 and 8 months of age). The safe use of enrofloxacin has not been established in large and giant breeds of dogs during the rapid growth phase.

For use in animals only. Keep out of reach of children.

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Federal law prohibits the extra label use of this drug in food-producing animals.

Quinolone-class drugs should be used with caution in animals with known or suspected Central Nervous System (CNS) disorders. In such animals, quinolones have, in rare instances, been associated with CNS stimulation which may lead to convulsive seizures.

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied • Beef And Non-Lactating Dairy
Composition / specifications
100 mg/mL
Swine
Indication

Enroflox 100 is indicated for the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis and Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae.

Enroflox 100 is indicated for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed.

Dosage

Administer, either by intramuscular or subcutaneous (behind the ear) injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb). Administered dose volume should not exceed 5 mL per injection site. For the control of colibacillosis, administrations should be initiated within the first 60 days post-weaning when clinical signs are present in at least 2% of the animals in the group.

Limitations

Animals intended for human consumption must not be slaughtered within five days of receiving a single-injection dose.

Cattle (Single- Dose Therapy)
Indication

Enroflox 100 is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non-lactating dairy cattle.

Dosage
Administer, by subcutaneous injection, a single dose of 7.5-12.5 mg/kg of body weight (3.4-5.7 mL/100 lb).
Limitations

Animals intended for human consumption must not be slaughtered within 28 days from the last treatment. This product is not approved for female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

Indication

Enroflox 100 is indicated for the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.

Dosage
Administer, by subcutaneous injection, a single dose of 7.5 mg/kg of body weight (3.4 ml/100 lb).
Limitations

Animals intended for human consumption must not be slaughtered within 28 days from the last treatment. This product is not approved for female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

Cattle (Multiple Day Therapy)
Indication
Enroflox 100 is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni in beef an non-lactating dairy cattle.
Dosage

Administer daily, a subcutaneous dose of 2.5-5 mg/kg of body weight (1.1-2.3 mL/100 lb). Treatment should be repeated at 24-hour intervals for three days. Additional treatments may be given on Days 4 and 5 to animals that have shown clinical improvement but not total recovery.

Limitations

Animals intended for human consumption must not be slaughtered within 28 days from the last treatment. This product is not approved for female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
22.7 mg/mL enrofloxacin
Label highlights
Indication
For the management of diseases in dogs associated with bacteria susceptible to enrofloxacin
Dosage
Administer 2.5 mg/kg as a single dose, followed by initiation of enrofloxacin tablet therapy
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
Each tablet contains 22.7, 68, or 136 mg of enrofloxacin.
<strong>Dogs</strong>
Indication
For the management of diseases associated with bacteria susceptible to enrofloxacin
Dosage
Administer orally at a rate to provide 5-20 mg/kg (2.27-9.07 mg/lb) of body weight as a single, daily dose, or divided into two equal doses at 12-hour intervals.

Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals
<strong>Cats</strong>
Indication
For the management of diseases associated with bacteria susceptible to enrofloxacin
Dosage
Administer orally at a rate to provide 5 mg/kg (2.27 mg/lb) of body weight as a single, daily dose, or divided into two equal doses at 12-hour intervals
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
22.7 mg/mL
Dogs
Indication
For the management of diseases in dogs associated with bacteria susceptible to enrofloxacin.
Dosage
Administer intramuscularly (IM) as a single injection at the rate of 1 mL/9.1 kg (20 lb) to provide 2.5 mg/kg (1.13 mg/lb). The injectable dose should be followed by oral tablet treatment in 12 hours.
Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
22.7 mg, 68 mg, 136 mg, and 272 mg
<strong>Dogs</strong>
Indication
For the management of diseases associated with bacteria susceptible to enrofloxacin
Dosage
Administer orally at a rate to provide 5-20 mg/kg (2.27 to 9.07 mg/lb) of body weight. Selection of a dose within the range should be based on clinical experience, the severity of disease, and susceptibility of the pathogen. Animals which receive doses in the upper-end of the dose range should be carefully monitored for clinical signs that may include inappetence, depression, and vomition
Limitations
Federal law restricts this drug to use by or on the order of licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals
<strong>Cats</strong>
Indication
For the management of diseases associated with bacteria susceptible to enrofloxacin
Dosage
Administer orally at 5 mg/kg (2.27 mg/lb) of body weight. The dose for dogs and cats may be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals. The doses should be continued for at least 2-3 days beyond cessation of clinical signs, to a maximum of 30 days
Limitations
Federal law restricts this drug to use by or on the order of licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals

FDA page: Open in Animal Drugs @ FDA

Usage

Fluoroquinolone antibiotic used for susceptible bacterial infections.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Use caution in young/growing animals (joint/cartilage risk). Avoid in pets with known fluoroquinolone sensitivity.

Side Effects

GI upset. In cats, high doses can cause retinal toxicity and vision loss.

Source: FDA openFDA • Reference

Top Reported Reactions (openFDA)

De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).

Digestive
Loss of appetite (1) • Dog Bloody diarrhoea (1) • Cat

Showing top 5 for Digestive.

Neurologic
Unsteady walking (1) • Cat

Showing top 5 for Neurologic.

Behavior
Circling - behavioural disorder (1) • Dog Biting -aggression (1) • Dog Anxiety (1) • Dog

Showing top 5 for Behavior.

Other
Crust (1) • Dog Cough (1) • Dog Confusion (1) • Dog Claw / hoof / nail disorder NOS (1) • Dog Cholangiohepatitis (1) • Cat
Show more (21)
Cellulitis (1) • Dog CARBON DIOXIDE LOW, BLOOD (1) • Cat Bumping into walls (1) • Dog Bruising (1) • Cat Bronchopulmonary inflammation (1) • Cat Blindness (1) • Cat Barking (1) • Dog Bacterial skin infection NOS (1) • Dog Azotaemia (1) • Cat Autoimmune disorder NOS (1) • Dog Aspiration pneumonia (1) • Dog Angioedema (1) • Dog Anal sac disorder (1) • Dog Anaemia NOS (1) • Dog Acidosis (1) • Cat Abscess NOS (1) • Dog Abnormal vision (1) • Dog Abnormal ultrasound finding (1) • Cat Abnormal radiograph finding (1) • Cat Abnormal histology NOS (1) • Dog Abdominal pain (1) • Cat

Showing top 5 for Other.

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Adverse Event Case Summaries (openFDA)

These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.

Dog, Bloodhound, Female, 5 year, 41.28 kilogram • Drug: MSK, Unknown, Dose: 400 Milligram per animal, Frequency: 1 per day • Reactions: Tiredness (lethargy), Stiffness NOS, Walking difficulty, Generalised weakness, Neutropenia… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074895
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 5.00 Year
  • Weight: 41.280 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Dose: 400 Milligram per animal
  • Frequency: 1 per day
Reactions Reported:
Tiredness (lethargy) Stiffness NOS Walking difficulty Generalised weakness Neutropenia Low platelet count Pain NOS Decreased appetite Vomiting Elevated liver enzymes NOS Fluid in abdomen NOS Liver disorder NOS Other immune system disorder NOS Fever Leucopenia NOS Distension of abdomen Hypoglycaemia Anaemia NOS Indigestion
Outcomes: Ongoing

Dog, Shepherd Dog - Belgian Malinois, Female, 1 year • Drug: MSK, Solution, Subcutaneous • Reactions: Injection site ulcer, Injection site scab • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074625
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 1.00 Year
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Subcutaneous
  • Form: Solution
Reactions Reported:
Injection site ulcer Injection site scab
Outcomes: Ongoing

Dog, Shih Tzu, Female, 11.68 year, 6.53 kilogram • Drug: MSK, Solution, Parenteral • Reactions: Not eating, Periorbital oedema, Fever, Local swelling, Nasal discharge… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074693
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 11.68 Year
  • Weight: 6.530 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Parenteral
  • Form: Solution
Reactions Reported:
Not eating Periorbital oedema Fever Local swelling Nasal discharge Stridor Face and neck swelling Sneezing Respiratory tract disorder NOS Biting -aggression
Outcomes: Ongoing

Dog, ['Hound (unspecified)', 'Dog (unknown)'], Male, 14.5 year, 35.83 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Aspiration pneumonia, Lack of efficacy - NOS, Medication error NOS, Anaemia NOS, Mass NOS… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074245
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 14.50 Year
  • Weight: 35.830 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Aspiration pneumonia Lack of efficacy - NOS Medication error NOS Anaemia NOS Mass NOS Skin ulcer Urine leakage Limb weakness Proprioception deficit Walking difficulty Barking Anxiety Urinary tract infection Diarrhea Cough Pain NOS
Outcomes: Ongoing

Dog, Terrier - Bull - American Pit, Male, 2 year, 29.03 kilogram • Drug: MSK, Unassigned, Oral • Reactions: Otitis externa, Trigeminus paralysis, Vomiting, Cough, Muscle atrophy… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-072504
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 2.00 Year
  • Weight: 29.030 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Unassigned
Reactions Reported:
Otitis externa Trigeminus paralysis Vomiting Cough Muscle atrophy Elevated serum alkaline phosphatase Elevated alanine aminotransferase Drooling Unusual stool colour Erythema Elevated gamma-glutamyl transferase Elevated total bilirubin Abnormal ultrasound finding Hepatic fibrosis Hepatitis Tiredness (lethargy) Angioedema Generalised rash Trouble breathing (dyspnea) Increased lung sounds Leucocytosis NOS Icterus Abnormal radiograph finding Jaw disorder
Outcomes: Ongoing

Cat, Maine Coon, Male, 8 year, 5.942 kilogram • Drug: MSK, Tablet, Unknown • Reactions: Pain NOS, Lameness, Not eating, Fever, High pancreatic-specific lipase… • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-071120
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 8.00 Year
  • Weight: 5.942 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Tablet
Reactions Reported:
Pain NOS Lameness Not eating Fever High pancreatic-specific lipase Tiredness (lethargy) Vomiting Lack of efficacy - NOS
Outcomes: Recovered/Normal

Cat, Domestic Shorthair, Male, 5 year, 5.9 kilogram • Drug: MSK, Solution, Unknown, Dose: 0.13 mL per dose • Reactions: Injection site skin change NOS, Injection site alopecia, Injection site weeping, Dehiscence, Injection site mucopurulent discharge… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-070057
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 5.00 Year
  • Weight: 5.900 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Solution
  • Dose: 0.13 mL per dose
Reactions Reported:
Injection site skin change NOS Injection site alopecia Injection site weeping Dehiscence Injection site mucopurulent discharge Injection site necrosis
Outcomes: Ongoing

Cat, Domestic Shorthair, Female, 14 year, 3.9 kilogram • Drug: MSK, Solution, Intravenous, Frequency: 1 per day • Reactions: Swollen limb, Epistaxis, Death by euthanasia, Malaise, Heart murmur… • Outcome: Euthanized

  • Report ID: USA-USFDACVM-2025-US-069686
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 14.00 Year
  • Weight: 3.900 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intravenous
  • Form: Solution
  • Frequency: 1 per day
Reactions Reported:
Swollen limb Epistaxis Death by euthanasia Malaise Heart murmur Neutropenia Thrombocytopenia Hypoalbuminaemia Increased drinking Haematuria Decreased urine concentration Elevated protein:creatinine ratio Dehydration Lymphopenia Abdominal pain Intestinal disorder NOS Abnormal radiograph finding Renal failure Renal disorder NOS Inflammatory bowel disorder Bronchopulmonary inflammation Bruising Anaemia NOS Tachycardia Pale mucous membrane Elevated alanine aminotransferase Prolonged one stage prothrombin time Intentional misuse Medication error NOS Polyuria Loss of appetite Azotaemia Necropsy performed Haemorrhage NOS Fracture Thyroid adenoma Pancreas disorder
Outcomes: Euthanized

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Overdose Information

Overdose may exacerbate GI and neurologic signs; in cats, high doses increase the risk of irreversible blindness. Supportive care is required.

Storage & Handling

Store at room temperature away from moisture.

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This medication has not been reviewed by a veterinarian yet.