CLOMIPRAMINE HYDROCHLORIDE | A074600 | WATSON LABORATORIES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition From e5 Pharma, LLC FDA-2014-P-1975 · 5 docket documents e5 Pharma, LLC submitted a suitability petition under section 512(n)(3) of the Federal Food, Drug, and Cosmetic Act requesting permission to file an Abbreviated New Animal Drug Application (ANADA) for Clomipramine Hydrochloride Chewable Tablets for dogs, a generic version of Clomicalm® Tablets (NADA | Other | 2014-11-19 | Granted | e5 Pharma, LLC |
PetMedicus Laboratories, Inc. - Citizen Petition FDA-2009-P-0162 · 4 docket documents PetMedicus Laboratories, Inc. filed a suitability petition under Section 512(n)(3) of the Federal Food, Drug, and Cosmetic Act requesting permission to file an abbreviated new animal drug application (ANADA) for generic clomipramine hydrochloride tablets for dogs in 10 mg and 80 mg strengths that di | Other | 2009-03-31 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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