ULTRAM

FDA-2023-P-2656 · 4 docket documents

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 · 6 docket documents

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 · 6 docket documents

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 · 6 docket documents

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 · 8 docket documents

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,