CARPROFEN | N018550 | HOFFMANN LA ROCHE INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition Approval Letter from FDA CVM to Douglass Oeller Consulti... FDA-2016-P-1991 Douglass Oeller Consulting, Inc., on behalf of Felix Pharmaceuticals Pvt. Ltd., filed a suitability petition under section 512(n)(3) of the Federal Food, Drug, and Cosmetic Act requesting approval to submit an abbreviated new animal drug application (ANADA) for carprofen soft chewable tablets for do | Suitability | 2016-09-26 | Open | — |
Suitability Petition Denial Response Letter from FDA CVM to Parnell Corporate... FDA-2014-P-1694 Parnell Corporate Services US, Inc. filed a suitability petition requesting approval to submit an abbreviated new animal drug application for a generic carprofen injectable solution that would differ from the reference listed drug RIMADYL in its inactive ingredients. The FDA denied the petition beca | Suitability | 2015-01-14 | Open | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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