MODRASTANE

FDA-2026-P-7889

Felix Pharmaceuticals Pvt. Ltd. filed a suitability petition requesting that the FDA determine whether a proposed drug product is suitable for abbreviated new drug application (ANDA) review or if full new drug application (NDA) procedures are required, though the specific drug name and requested det

FDA-2026-P-4061

Felix Pharmaceuticals Pvt. Ltd. submitted this 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 oral suspension formulation of Trilostane at a strength of 20 mg/mL, which differs from t

FDA-2026-P-0529

Felix Pharmaceuticals Pvt. Ltd., based in Dublin, Ireland, filed this Section 512(n)(3) suitability petition requesting permission to submit an abbreviated new animal drug application (ANADA) for a generic oral solution formulation of Trilostane for dogs, which would differ from the approved pioneer

FDA-2025-P-6404

Felix Pharmaceuticals Pvt. Ltd. submitted this 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 Trilostane soft chewable tablet that differs from the pioneer product Vetoryl (NADA 141-29

FDA-2023-P-0851

Norbrook Laboratories Limited 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 for Trilostane 20 mg/mL Oral Suspension, a generic version of the pioneer product Vetoryl Capsule