ULTRAM

FDA-2024-P-3090

The FDA approved a suitability petition for griseofulvin ultramicrosize oral suspension 250 mg/5 mL, allowing applicants to reference an existing NDA as the basis for submitting ANDAs for this formulation. This approval facilitated generic development of this antifungal product by establishing that

FDA-2021-P-0036

Hyman, Phelps & McNamara, P.C. filed a petition requesting permission to submit an Abbreviated New Drug Application for Tramadol Hydrochloride Tablets at a 75 mg strength, with Ultram Tablets at 50 mg and 100 mg as the listed reference drug product approved under NDA 020281. The FDA approved the pet

FDA-2021-P-0036

The law firm Hyman, Phelps & McNamara, PC filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Tramadol Hydrochloride Tablets, 75 mg (scored), suitable for submission as an Abbreviated New Drug Application (ANDA). The peti

FDA-2007-P-0186

Purdue Pharma LP filed this citizen petition on March 13, 2007, requesting that the FDA refuse approval of Cipher Pharmaceuticals' NDA for CIP-TRAMADOL ER, a 24-hour extended-release tramadol formulation, unless Cipher either provides appropriate patent certification regarding U.S. Patent No. 6,254,