BANAN

FDA-2025-P-5433

Felix Pharmaceuticals Pvt. Ltd. submitted this Section 512(n)(3) suitability petition requesting permission to file an abbreviated new animal drug application for a generic Cefpodoxime Proxetil powder for oral suspension for dogs, which differs in dosage form from the pioneer product Simplicefo (coa

FDA-2025-P-0983

Felix Pharmaceuticals Pvt. Ltd. submitted this 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 Cefpodoxime Proxetil powder for oral suspension for dogs, which differ

FDA-2023-P-2728

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 cefpodoxime proxetil chewable tablet, which differs in dosage form from th

FDA-2023-P-2728

Felix Pharmaceuticals Pvt. Ltd. filed a citizen petition regarding cefpodoxime proxetil chewable tablets, requesting a determination of suitability for approval under the abbreviated new drug application pathway.

FDA-2023-P-2728

Felix Pharmaceuticals Pvt. Ltd. filed a citizen petition requesting FDA suitability determination for SIMPLICEF, a cefpodoxime proxetil tablet formulation. The petition seeks regulatory eligibility to pursue abbreviated new drug application (ANDA) pathways for this antibiotic product.

FDA-2023-P-2728

Felix Pharmaceuticals Pvt. Ltd. submitted a petition under Section 512(n)(3) of the Federal Food, Drug and Cosmetic Act requesting permission to file an abbreviated new animal drug application for a generic compressed chewable tablet formulation of Cefpodoxime Proxetil, which differs from the pionee

FDA-2020-P-2234

Ray Law Firm, PLLC 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 generic cefpodoxime proxetil tablets that would add a 50 mg strength and eliminate tablet scoring

FDA-2020-P-2234

Harry B. Ray of Ray Law Firm, PLLC submitted a citizen petition under section 512(n)(3) of the Federal Food, Drug and Cosmetic Act requesting approval to file an Abbreviated New Animal Drug Application for Cefpodoxime Proxetil tablets with the addition of a 50mg strength tablet for treating skin inf

FDA-2016-P-3428

Douglass Oeller Consulting, Inc. as US Agent for Felix Pharmaceuticals Pvt. Ltd. submitted an amendment to suitability petition FDA-2016-P-3428 under Section 512(n)(3) of the Federal Food, Drug and Cosmetic Act to correct a typographical error in the NADA number for the reference listed new animal d

FDA-2016-P-3428

Douglass Oeller Consulting, Inc., on behalf of Felix Pharmaceuticals Pvt. Ltd., filed a petition regarding Simplicef requesting that the FDA determine the suitability of the product for approval or continued marketing. The petition seeks FDA guidance on the regulatory pathway and manufacturing or fo

FDA-2016-P-3428

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 file an Abbreviated New Animal Drug Application (ANADA) for a generic compressed soft chewable

FDA-2013-P-0996

Piedmont Animal Health filed this 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 cefpodoxime proxetil soft chewable tablet for dogs, which differs from the pioneer