RIMADYL

FDA-2024-P-4728

Aurora Pharmaceutical, Inc. filed a suitability petition that was approved by the FDA's Center for Veterinary Medicine, permitting the company to submit an abbreviated new animal drug application for a generic carprofen oral solution for dogs, which differs in dosage form from the reference listed n

FDA-2024-P-4728

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

FDA-2022-P-1642

Noble Pharma, LLC 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 extruded chewable tablet that differs in dosage form from the reference listed

FDA-2022-P-1642

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

FDA-2018-P-2407

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

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

FDA-2016-P-1991

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

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

FDA-2012-P-0492

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

FDA-2009-P-0462

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

FDA-2009-P-0462

Piedmont Animal Health filed a petition on September 21, 2009, requesting FDA permission to file an Abbreviated New Animal Drug Application for a generic carprofen soft chewable tablet, a new animal drug differing from the pioneer product RIMADYL (carprofen) approved under NADA 141-111. The petition