ULTRAM

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-2023-P-2656

Hyman, Phelps & McNamara, P.C. filed this petition pursuant to sections 505(j) and 505(w) of the Federal Food, Drug, and Cosmetic Act and requesting that the FDA determine whether ULTRAM (tramadol hydrochloride) Tablets, 50 mg, approved under NDA 020281 and held by Janssen Pharmaceuticals, Inc., was

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-2019-P-5593

Hyman, Phelps & McNamara, P.C. filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Tramadol Hydrochloride Tablets, 25 mg, suitable for consideration in an ANDA, with ULTRAM (tramadol hydrochloride) Tablets, 50 mg, approved

FDA-2009-P-0429

Lachman Consultant Services, Inc. filed this petition under Section 505(b)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Tramadol Hydrochloride and Acetaminophen Tablets, 75 mg/650 mg suitable for consideration in an abbreviated new drug application (ANDA), based o

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,