CLINDAMYCIN HYDROCHLORIDE | A061809 | PHARMACIA AND UPJOHN CO
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Approval of Suitability Petition from FDA CVM to Schafer Veterinary Consultan... FDA-2021-P-0086 · 4 docket documents Schafer Veterinary Consultants, LLC, filed suitability petition FDA-2021-P-0086 requesting permission to submit an abbreviated new animal drug application for a generic clindamycin hydrochloride tablet in a different dosage form from the reference listed new animal drug Antirobe® (clindamycin hydroc | Suitability | 2021-04-08 | Granted | FDA CVM to Schafer Veterinary Consultants, LLC |
Piedmont Animal Health - Citizen Petition FDA-2013-P-1101 · 3 docket documents Piedmont Animal Health filed a suitability petition under section 512(n)(3) of the Federal Food, Drug, and Cosmetic Act requesting permission to submit an Abbreviated New Animal Drug Application for clindamycin hydrochloride as a soft chewable tablet for canine use, which would differ from the pione | Other | 2013-09-25 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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