VANTIN

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

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., 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-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