CARPROFEN | N018550 | HOFFMANN LA ROCHE INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Aurora Pharmaceutical, Inc. FDA-2024-P-4728 · 4 docket documents Aurora Pharmaceutical, Inc. filed a suitability petition under Section 512(n)(3) of the Federal Food, Drug, and Cosmetic Act on October 8, 2024, requesting FDA permission to submit an abbreviated new animal drug application for Carprofen Oral Solution 5.0% w/v as a generic animal drug that differs i | Suitability | 2024-10-09 | Granted | Aurora Pharmaceutical, Inc. |
Suitability Petition from Noble Pharma, LLC FDA-2022-P-1642 · 5 docket documents Noble Pharma, LLC filed this suitability petition on July 20, 2022, pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. § 314.93, requesting FDA permission to file an Abbreviated New Animal Drug Application for a generic chicken liver-flavored soft chewable tab | Suitability | 2022-07-21 | Granted | Noble Pharma, LLC |
Citizen Petition from Ray Law Firm, PLLC FDA-2018-P-2407 · 3 docket documents Harry B. Ray of Ray Law Firm, PLLC submitted this citizen petition under Section 512(n)(3) of the Federal Food, Drug, and Cosmetic Act to pursue approval of an Abbreviated New Animal Drug Application for generic Carprofen Chewable Tablets for dogs, requesting the addition of 37.5mg and 50mg tablet s | Other | 2018-06-21 | Open | Ray Law Firm, PLLC |
Citizen Petition from Douglass Oeller Consulting, Inc. (Felix Pharmaceuticals... FDA-2016-P-1991 · 4 docket documents Douglass Oeller Consulting, Inc., as US Agent for Felix Pharmaceuticals Pvt. Ltd., 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 (ANADA) for a generic carprofen compressed sof | Other | 2016-07-12 | Granted | Douglass Oeller Consulting, Inc. (Felix Pharmaceuticals Pvt. Ltd) |
Suitability Petition Denial Response Letter from FDA CVM to Parnell Corporate... FDA-2014-P-1694 · 4 docket documents 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 | Denied | — |
Med-Pharmex, Inc. - Citizen Petition FDA-2012-P-0492 · 3 docket documents Med-Pharmex, Inc. filed a suitability petition under Section 512(n)(3) of the Federal Food, Drug, and Cosmetic Act requesting approval to file an Abbreviated New Animal Drug Application (ANADA) for carprofen oral paste 2.5%, proposing a change in dosage form from the reference listed new animal drug | Other | 2012-05-17 | Granted | — |
Piedmont Animal Health - Citizen Petition FDA-2009-P-0462 · 7 docket documents Piedmont Animal Health 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 a generic carprofen soft chewable tablet for canines that differs from the pioneer product | Other | 2009-09-30 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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