Meds A-Z
Clindamycin
Detailed information about Clindamycin
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Sign in to continueReviewed / Updated / Sources
Reviewed: Not available
Updated: February 12, 2026, 10:44 PM UTC
- FDA application profile · official_label
- FDA application profile · official_label
- Medication usage source · fda_animal_drugs
- ClindaMed™ Oral Drops · official_label
- openFDA case USA-USFDACVM-2025-US-050728 · adverse_reaction
Pet Owner Quick Guide
Start here first for the simple next-step summary.
Used for:
For the treatment of skin infections (wounds and abscesses) due to susceptible strains of coagulase-positive staphylococci ( Staphylococcus aureus or S. intermedius ), deep wounds and abscesses due to susceptible strains...
What to watch for:
- Vomiting (1 reports)
- Palpebral disorder NOS (1 reports)
- Open mouth breathing (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.
Regulatory restrictions are shown in Vet View.
What to 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?
Safety & side effects
What to watch:
- Vomiting
- Palpebral disorder NOS
- Open mouth breathing
Most reported reactions:
- Vomiting (1 reports)
- Palpebral disorder NOS (1 reports)
- Open mouth breathing (1 reports)
When to call your vet:
- Repeated vomiting or diarrhea.
- Severe lethargy (hard to wake, very low energy).
- Collapse or fainting.
- Trouble breathing.
Data freshness: source data appears current.
Latest refresh: Mar 21, 2026, 10:04 a.m.
- Medication catalog: Source Roxee | Refreshed Feb 12, 2026, 10:44 PM UTC
-
Animal Drugs @ FDA:
Source FDA
| Refreshed Mar 21, 2026, 10:00 AM UTC
Applications/products are imported from FDA export data.
-
Animal Drugs @ FDA previews:
Source FDA
| Refreshed Feb 9, 2026, 3:05 AM UTC
Label highlights/doc links are fetched from FDA preview endpoints.
-
Animal Drug Product Listing Directory (NDC):
Source FDA
| Refreshed Mar 21, 2026, 10:01 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).
- openFDA reaction terms: Source FDA openFDA | Refreshed Mar 21, 2026, 10:04 AM UTC
- openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:22 AM UTC
Clindamycin
Drug type: Generic ingredient • Branded profile • FDA branded products available
Species: Both
Manufacturer: Not available (source)
Quick Facts
Official label facts first, then secondary summaries. Marketing content is separated below.
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/200813 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov/adafda/views/#/home/previewsearch/120161 · official_label · FDA application profile
- https://animaldrugsatfda.fda.gov · fda_animal_drugs · Medication usage source
Warnings / Contraindications
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian
- High: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian
- https://animaldrugsatfda.fda.gov · fda_animal_drugs · Contraindication source
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.
Grouped by Body System
Most Reported Reactions
| Reaction | Body system | Cases | Species | Serious cases |
|---|---|---|---|---|
| Digestive | 1 | Dog | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Dog | 1 | |
| Other | 1 | Cat | 1 | |
| Other | 1 | Dog | 1 |
Species coverage: Dog (22) Cat (10)
View detailed reaction table
| Reaction | Body system | Species | Seriousness | Frequency | Reports |
|---|---|---|---|---|---|
| Digestive | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Effectiveness | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Skin & allergy | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Neurologic | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Digestive | Dog | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Cat | Serious | - | 1 | |
| Other | Dog | Serious | - | 1 | |
| Skin & allergy | Cat | Non-serious | - | 1 | |
| Other | Cat | Non-serious | - | 1 | |
| Other | Dog | Serious | - | 1 |
- https://api.fda.gov/animalandveterinary/event.json · adverse_reaction · openFDA case USA-USFDACVM-2025-US-050728
Documents
Owner handouts and official technical documents are grouped for faster access.
Owner handouts (0)
- No owner handouts linked yet.
Official label / PI (0)
- No official label or package insert links yet.
SPL (10)
-
Clindamycin Hydrochloride Tablets
· SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/17488/Clindamycin%20Hydrochloride%20Tablets
-
Antirobe® Capsules
· SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/1741/Antirobe%C2%AE%20Capsules
-
ClindaMed™ Oral Drops
· SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/1777/ClindaMed%E2%84%A2%20Oral%20Drops
-
Clindamycin Hydrochloride Oral Drops
· SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/210/Clindamycin%20Hydrochloride%20Oral%20Drops
-
Antirobe Aquadrops®
· SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/510/Antirobe%20Aquadrops%C2%AE
-
Clindamycin Hydrochloride Oral Liquid
· SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/319/Clindamycin%20Hydrochloride%20Oral%20Liquid
-
Clindamycin Hydrochloride Capsules
· SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/107/Clindamycin%20Hydrochloride%20Capsules
-
ClindaRobe™
· SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/221/ClindaRobe%E2%84%A2
-
Clinsol®
· SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/159/Clinsol%C2%AE
-
Clintabs®
· SPL
https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/155/Clintabs%C2%AE
FOI (15)
-
FOI Summary oA 200-813 Approved June 27, 2025.pdf
· FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/17171
-
ucm069817.pdf
· FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/380
-
UCM355629.pdf
· FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1226
-
ucm061348.pdf
· FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1143
-
ucm069874.pdf
· FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/411
-
UCM454278.pdf
· FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/412
-
N135940_Supp_11_16_89(2).pdf
· FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1703
-
UCM061610.pdf
· FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/994
-
UCM061609.pdf
· FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/993
-
A200193_Org_8_1_1997.pdf
· FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1426
-
ucm061743.pdf
· FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1048
-
ucm061742.pdf
· FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1047
-
ucm061338.pdf
· FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1134
-
ucm061719.pdf
· FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1043
-
ucm061770.pdf
· FOI
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1064
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/17171 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/17488/Clindamycin%20Hydrochloride%20Tablets · document · SPL
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/380 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/1741/Antirobe%C2%AE%20Capsules · document · SPL
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1226 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/1777/ClindaMed%E2%84%A2%20Oral%20Drops · document · SPL
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/1143 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/spl/file/210/Clindamycin%20Hydrochloride%20Oral%20Drops · document · SPL
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/411 · document · FOI
- https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/412 · document · FOI
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.
- Medication catalog: Source Roxee | Refreshed Feb 12, 2026, 10:44 PM UTC
-
Animal Drugs @ FDA:
Source FDA
| Refreshed Mar 21, 2026, 10:00 AM UTC
Applications/products are imported from FDA export data.
-
Animal Drugs @ FDA previews:
Source FDA
| Refreshed Feb 9, 2026, 3:05 AM UTC
Label highlights/doc links are fetched from FDA preview endpoints.
-
Animal Drug Product Listing Directory (NDC):
Source FDA
| Refreshed Mar 21, 2026, 10:01 AM UTC
Package/product NDCs from FDA’s electronic listing directory (XLS).
- openFDA reaction terms: Source FDA openFDA | Refreshed Mar 21, 2026, 10:04 AM UTC
- openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:22 AM UTC
Diagnosis-code mappings are not available for this medication yet.
Counseling and Monitoring Highlights
Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.
- Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian (Contraindication, High)
Identifiers & Packages
Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.
| Package NDC | Product NDC | Form / Route | Status |
|---|---|---|---|
| 13985-957-25 | 13985 | - | |
| 51311-400-40 | 51311 | - | |
| 51311-402-75 | 51311 | - | |
| 51311-404-15 | 51311 | - | |
| 54771-3043-1 | 54771 | - | |
| 54771-3044-1 | 54771 | - | |
| 54771-3045-1 | 54771 | - | |
| 54771-3179-1 | 54771 | - | |
| 54771-3179-2 | 54771 | - | |
| 69043-013-20 | 69043 | - | |
| 69043-014-20 | 69043 | - | |
| 69043-015-01 | 69043 | - | |
| 69043-015-05 | 69043 | - | |
| 69043-016-01 | 69043 | - | |
| 86101-052-18 | 86101 | - | |
| 86101-053-15 | 86101 | - | |
| 86101-054-11 | 86101 | - | |
| 86136-147-03 | 86136 | - | |
| 86136-148-03 | 86136 | - |
Enriched Documents
Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.
-
FOI Summary oA 200-813 Approved June 27, 2025.pdf
• FOI summary • Official
• July 1, 2025
FDA FOI summary for application 200813
-
ucm069817.pdf
• FOI summary • Official
• Dec. 10, 2019
FDA FOI summary for application 120161
-
UCM355629.pdf
• FOI summary • Official
• Oct. 2, 2018
FDA FOI summary for application 200538
-
ucm061348.pdf
• FOI summary • Official
• Dec. 27, 2017
FDA FOI summary for application 200398
-
N135940_Supp_11_16_89(2).pdf
• FOI summary • Official
• July 11, 2017
FDA FOI summary for application 135940
-
UCM454278.pdf
• FOI summary • Official
• July 11, 2017
FDA FOI summary for application 135940
-
ucm069874.pdf
• FOI summary • Official
• July 11, 2017
FDA FOI summary for application 135940
-
A200193_Org_8_1_1997.pdf
• FOI summary • Official
• May 22, 2017
FDA FOI summary for application 200193
-
UCM061609.pdf
• FOI summary • Official
• May 22, 2017
FDA FOI summary for application 200193
-
UCM061610.pdf
• FOI summary • Official
• May 22, 2017
FDA FOI summary for application 200193
-
ucm061338.pdf
• FOI summary • Official
• June 1, 2016
FDA FOI summary for application 200383
-
ucm061770.pdf
• FOI summary • Official
• June 1, 2016
FDA FOI summary for application 200316
-
ucm061742.pdf
• FOI summary • Official
• June 1, 2016
FDA FOI summary for application 200298
-
ucm061743.pdf
• FOI summary • Official
• June 1, 2016
FDA FOI summary for application 200298
-
ucm061719.pdf
• FOI summary • Official
• June 1, 2016
FDA FOI summary for application 200291
Data Sources & Change Log
Every non-trivial field is expected to include provenance and update timestamps.
- contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed v… (Official, 2026-02-12)
- side_effects: Top reported reactions (openFDA): Vomiting, Death by euthanasia, Lethargy (see also Central nervous system depression in 'Neurological'), Anorexia, Other abnor… (Official, 2026-02-12)
- usage: For the treatment of skin infections (wounds and abscesses) due to susceptible strains of coagulase-positive staphylococci ( Staphylococcus aureus or S. interm… (Official, 2026-02-12)
- side_effects updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
- contraindications updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
- usage updated 2026-02-12 22:44 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 |
|---|---|---|---|---|
|
Clindamycin Hydrochloride Tablets
RX
Clindamycin Hydrochloride
Tablet
• Oral
|
Felix Pharmaceuticals Pvt. Ltd. | ANADA 200-813 | Approved | Jul 1, 2025 |
|
Antirobe® Capsules
RX
Clindamycin Hydrochloride
Capsule
• Oral
|
Zoetis Inc. | NADA 120-161 | Approved | Dec 10, 2019 |
|
ClindaMed™ Oral Drops
RX
Clindamycin
Liquid
• Oral
|
Bimeda Animal Health Limited | ANADA 200-538 | Approved | Oct 2, 2018 |
|
Clindamycin Hydrochloride Oral Drops
RX
Clindamycin Hydrochloride
Liquid (Solution)
• Oral
|
First Priority, Inc. | ANADA 200-398 | Approved | Dec 27, 2017 |
|
Antirobe Aquadrops®
RX
Clindamycin Hydrochloride
Liquid (Solution)
• Oral
|
Zoetis Inc. | NADA 135-940 | Approved | Jul 11, 2017 |
|
Clindamycin Hydrochloride Oral Liquid
RX
Clindamycin Hydrochloride
Liquid (Solution)
• Oral
|
Cronus Pharma Specialities India Private Ltd. | ANADA 200-193 | Approved | May 22, 2017 |
|
Clindamycin Hydrochloride Capsules
RX
Clindamycin Hydrochloride
Capsule
• Oral
|
Cronus Pharma Specialities India Private Ltd. | ANADA 200-298 | Approved | Jun 1, 2016 |
|
ClindaRobe™
RX
Clindamycin Hydrochloride
Capsule
• Oral
|
Teva Canada Ltd. | ANADA 200-383 | W | Jun 1, 2016 |
|
Clinsol®
RX
Clindamycin Hydrochloride
Liquid (Solution)
• Oral
|
Virbac AH, Inc. | ANADA 200-291 | Approved | Jun 1, 2016 |
|
Clintabs®
RX
Clindamycin Hydrochloride
Tablet
• Oral
|
Virbac AH, Inc. | ANADA 200-316 | 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.
Composition / specifications
For the treatment of skin infections (wounds and abscesses) due to susceptible strains of coagulase-positive staphylococci (Staphylococcus aureus or S. intermedius), deep wounds and abscesses due to susceptible strains of Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum, and Clostridium perfringens, dental infections due to susceptible strains of S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens, and osteomyelitis due to susceptible strains of S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens.
Wounds, abscesses, and dental infections: 2.5 to 15 mg per pound (/lb) body weight every 12 hours for a maximum of 28 days. Osteomyelitis: 5.0 to 15 mg/lb body weight every 12 hours for a minimum of 28 days.
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
For the treatment of skin infections (wounds and abscesses) due to susceptible strains of coagulase-positive staphylococci (Staphylococcus aureus or S. intermedius), deep wounds and abscesses due to susceptible strains of Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum, and Clostridium perfringens, dental infections due to susceptible strains of S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens, and osteomyelitis due to susceptible strains of S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens.
Wounds, abscesses, and dental infections: 2.5 to 15 milligrams per pound of body weight every 12 hours for a maximum of 28 days. Osteomyelitis: 5.0 to 15 milligrams per pound of body weight every 12 hours for a minimum of 28 days.
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
Skin infections (wounds and abscesses) due to coagulase positive staphylococci (Staphylococcus aureus or Staphylococcus intermedius). Deep wounds and abscesses due to Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum and Clostridium perfringens.
Dental infections due to Staphylococcus aureus, Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum and Clostridium perfringens.
Osteomyelitis due to Staphylococcus aureus, Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum and Clostridium perfringens.
Osteomyelitis: 5.0 to 15 mg/lb body weight every 12 hours for a minimum of 28 days.
Dental infections due to Staphylococcus aureus, Staphylococcus intermedius, Streptococcus spp., Clostridium perfringens and Bacteroides fragilis.
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
For the treatment of skin infections (wounds and abscesses) due to susceptible strains of coagulase-positive staphylococci (Staphylococcus aureus or S. intermedius), deep wounds and abscesses due to susceptible strains of Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum, and Clostridium perfringens, dental infections due to susceptible strains of S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens, and osteomyelitis due to susceptible strains of S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens.
For the treatment of skin infections (wounds and abscesses) due to susceptible strains of S. aureus, S. intermedius, Streptococcus species, deep wounds and abscesses due to susceptible strains of Clostridium perfringens and Bacteroides fragilis, and dental infections due to susceptible strains of S. aureus, S. intermedius, Streptococcus species, C. perfringens, and B. fragilis.
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
FDA page: Open in Animal Drugs @ FDA
Composition / specifications
FDA page: Open in Animal Drugs @ FDA
Official Documents (FDA)
Direct links to FDA-hosted PDFs and SPL packages (when available).
-
Summary
For the treatment of skin infections (wounds and abscesses) due to susceptible strains of coagulase-positive staphylococci (Staphylococcus aureus or S. intermedius), deep wounds and abscesses due to susceptible strains of Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum, and Clostridium perfringens, dental infections due to susceptible strains of S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens, and osteomyelitis due to susceptible strains of S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens.
FDA page: Open in Animal Drugs @ FDA
-
FOI ucm069817.pdf
Summary
The supplement provides for the use of clindamycin hydrochloride (ANTIROBE Capsules) in dogs at a dose range of 2.5-15 mg/lb body weight every 12 hours for skin infections (wounds and abscesses), deep wounds and abscesses, and dental infections. It also provides for a dose range in dogs of 5-15 mg/lb every 12 hours for osteomyelitis. In addition, this supplement provides for the addition of a 300 mg capsule. This supplement also provides for the addition of recent MIC data derived from U.S. diagnostic laboratories.
- Antirobe® Capsules (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
FOI UCM355629.pdf
Summary
For the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below:
Dogs: Skin infections (wounds and abscesses) due to coagulase positive staphylococci (Staphylococcus aureus or Staphylococcus intermedius). Deep wounds and abscesses due to Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum and Clostridium perfringens.
Dental infections due to Staphylococcus aureus, Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum and Clostridium perfringens.
Osteomyelitis due to Staphylococcus aureus, Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum and Clostridium perfringens.Cats: Skin infections (wounds and abscesses) due to Staphylococcus aureus, Staphylococcus intermedius, Streptococcus spp. Deep wounds and abscesses due to Clostridium perfringens and Bacteroides fragilis.
Dental infections due to Staphylococcus aureus, Staphylococcus intermedius, Streptococcus spp., Clostridium perfringens and Bacteroides fragilis.
- ClindaMed™ Oral Drops (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
FOI ucm061348.pdf
Summary
Clindamycin Hydrochloride Oral Drops (for use in dogs and cats) is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below:
Dogs: Skin infections (wounds and abscesses) due to coagulase positive staphylococci (Staphylococcus aureus or Staphyloccus intermedius). Deep wounds and abscesses due
to Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum, and Clostridium perfringens. Dental infections due to S. auerus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens. Osteomyelitis due to S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens.
Cats: Skin infections (wounds and abscesses) due to Staphylococcus aureus, Staphylococcus intermedius and Streptococcus spp. Deep wounds and infections due to Clostridium perfringens and Bacteroides fragilis. Dental infections due to S. aureus, S. intermedius, Streptococcus spp., C. perfringens, and B. fragilis.
FDA page: Open in Animal Drugs @ FDA
-
FOI ucm069874.pdf
Summary
The supplement provides for the use of clindamycin hydrochloride (ANTIROBE AQUADROPS Liquid) in dogs at a dose range of 2.5-15 mg/lb body weight every 12 hours for skin infections (wounds and abscesses), deep wounds and abscesses, and dental infections. It also provides for a dose range in dogs of 5-15 mg/lb every 12 hours for osteomyelitis. In addition, this supplement provides for an expanded dose range of 5-15 mg/lb every 24 hours in cats. This supplement also provides for the addition of recent MIC data derived from a survey of U.S. diagnostic laboratories. -
FOI UCM454278.pdf
Summary
This supplement provides for the use of clindamycin HCl (ANTIROBE AQUADROPS Liquid) in cats for new indications. -
Summary
This supplemental application provides for the following additional claims: Aerobic bacteria: for the treatment of dental infections caused by susceptible strains of Staphylococcus aureus. Anaerobic bacteria: for the treatment of soft tissue infections (deep wounds and abscesses), dental infections, and osteomyelitis caused by or associated with susceptible strains of Bacteroides fragilis, Bacteroides melaninogenicus, Fusobacterium necrophorum and Clostridium perfringens.
- Antirobe Aquadrops® (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
FOI UCM061610.pdf
Summary
The supplement provides for approval of a dose range and revised indications for use of Clindamycin Hydrochloride Oral Liquid in dogs and cats which was approved for the pioneer product under NADA 135-940 (67 FR 54954, Aug. 27, 2002) with no exclusivity period. The expanded range was changed from a point dose of 2.5 mg/lb. in dogs to an expanded range of 2.5 to 15 mg/lb. The change in cats was from a range of 5.0 to 10.0 mg/lb. to a range of 5.0 to 15.0 mg/lb. The revised indications provides for a change in the words ‘soft tissues infections’ to ‘skin infections’ for dogs and cats. -
FOI UCM061609.pdf
Summary
provides for the addition of feline claims to the previous approved label for use in canine only. -
Summary
For therapy of wounds, abscesses, dental infections, and osteomyelitis.
FDA page: Open in Animal Drugs @ FDA
-
FOI ucm061743.pdf
Summary
For the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed: Skin infections (wounds and abscesses) due to coagulase positive staphylococci (Staphylococcus aureus or S. intermedius), deep wounds and abscesses due to Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum, and Clostridium perfringens, dental infections due to S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens. -
FOI ucm061742.pdf
Summary
For the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed in the approval.
FDA page: Open in Animal Drugs @ FDA
-
FOI ucm061338.pdf
Summary
CLINDAROBE Capsules is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below:
- ClindaRobe™ (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
FOI ucm061719.pdf
Summary
For the treatment of infections caused by susceptible strains of the designated microorganism in the specific conditions listed for Dogs and Cats.
- Clinsol® (ZIP)
FDA page: Open in Animal Drugs @ FDA
-
FOI ucm061770.pdf
Summary
For treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed in the approval
- Clintabs® (ZIP)
FDA page: Open in Animal Drugs @ FDA
Usage
For the treatment of skin infections (wounds and abscesses) due to susceptible strains of coagulase-positive staphylococci ( Staphylococcus aureus or S. intermedius ), deep wounds and abscesses due to susceptible strains of Bacteroides fragilis , Prevotella melaninogenicus , Fusobacterium necrophorum , and Clostridium perfringens , dental infections due to susceptible strains of S. aureus , B. fragilis , P. melaninogenicus , F. necrophorum , and C. perfringens , and osteomyelitis due to susceptible strains of S. aureus , B. fragilis , P. melaninogenicus , F. necrophorum , and C. perfringens . For the treatment of skin infections (wounds and abscesses) due to susceptible strains of coagulase-positive staphylococci ( Staphylococcus aureus or S. intermedius ), deep wounds and abscesses due to susceptible strains of Bacteroides fragilis , Prevotella melaninogenicus, Fusobacterium necrophorum , and Clostridium perfringens , dental infections due to susceptible strains of S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens , and osteomyelitis due to susceptible strains of S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum , and C. perfringens . For the treatment of skin infections (wounds and abscesses) due to susceptible strains of S. aureus, S. intermedius, Streptococcus species, deep wounds and abscesses due to susceptible strains of Clostridium perfringens and Bacteroides fragilis , and dental infections due to susceptible strains of S. aureus, S. intermedius, Streptococcus species, C. perfringens , and B. fragilis .
Source: FDA Animal Drugs @ FDA • Reference
Contraindications
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed veterinarian
Top Reported Reactions (openFDA)
De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).
Showing top 5 for Digestive.
Showing top 5 for Skin & allergy.
Showing top 5 for Neurologic.
Showing top 5 for Effectiveness.
Show more (21)
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, Sheepdog - Shetland, Female, 4.5 year, 9 kilogram • Drug: MSK, Unknown • Reactions: Inappropriate urination, Polyuria • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2025-US-055980
- Serious AE: No
- Treated For AE: No
- Sex: Female
- Age: 4.50 Year
- Weight: 9.000 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
Cat, Domestic Shorthair, Male, 7 year, 6.4 kilogram • Drug: MSK, Oral • Reactions: Application site excoriation, Application site hair loss • Outcome: Ongoing
- Report ID: USA-USFDACVM-2025-US-055392
- Serious AE: No
- Treated For AE: No
- Sex: Male
- Age: 7.00 Year
- Weight: 6.400 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Oral
Dog, ['Coonhound (unspecified)', 'Dog (unknown)'], Male, 5 year, 34.382 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Hives • Outcome: Recovered/Normal
- Report ID: USA-USFDACVM-2025-US-053111
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Male
- Age: 5.00 Year
- Weight: 34.382 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
- Form: Unassigned
Dog, Retriever - Chesapeake Bay, Female, 5 year, 22.498 kilogram • Drug: MSK, Unassigned, Oral • Reactions: Not drinking, Vomiting, Tremors, Walking difficulty, Hyperaesthesia… • Outcome: Ongoing
- Report ID: USA-USFDACVM-2025-US-055136
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Female
- Age: 5.00 Year
- Weight: 22.498 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Oral
- Form: Unassigned
Cat, Siamese, Male, 15 year, 5.171 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Skin lesion NOS, Skin disorders NOS, Licking, Increased skin sensitivity, Skin necrosis • Outcome: Ongoing
- Report ID: USA-USFDACVM-2025-US-052046
- Serious AE: Yes
- Treated For AE: Yes
- Sex: Male
- Age: 15.00 Year
- Weight: 5.171 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Unknown
- Form: Unassigned
Cat, Domestic Shorthair, Male, 4.5 year, 6.98 kilogram • Drug: MSK, Oral • Reactions: Hiding, Open mouth breathing, Not urinating, Not drinking, Sedation… • Outcome: Died
- Report ID: USA-USFDACVM-2025-US-051262
- Serious AE: Yes
- Treated For AE: No
- Sex: Male
- Age: 4.50 Year
- Weight: 6.980 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
- Route: Oral
Cat, Manx, Female, 3 year, 3.629 kilogram • Drug: MSK • Reactions: Vocalisation, Unequal pupils • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2025-US-050802
- Serious AE: No
- Treated For AE: No
- Sex: Female
- Age: 3.00 Year
- Weight: 3.629 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
Cat, Domestic Shorthair, Male, 14 year, 5.352 kilogram • Drug: MSK • Reactions: Not eating, Underdose • Outcome: Outcome Unknown
- Report ID: USA-USFDACVM-2025-US-051985
- Serious AE: No
- Treated For AE: No
- Sex: Male
- Age: 14.00 Year
- Weight: 5.352 Kilogram
- Case-reported brand: MSK
- Case-reported manufacturer: MSK
Data source: FDA openFDA Animal & Veterinary adverse event reports.
Overdose Information
No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.
Storage & Handling
No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.
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