GLUCOPHAGE

FDA-2026-P-7602 · 7 docket documents

Senores Pharmaceuticals, Inc. filed a citizen petition requesting that the FDA determine the suitability of an active pharmaceutical ingredient for use in drug products, evaluating whether the ingredient meets established standards for safety, quality, and efficacy in pharmaceutical manufacturing an

FDA-2026-P-5991 · 8 docket documents

Hyman, Phelps & McNamara, P.C. filed this suitability petition to request FDA determination regarding whether a drug substance or excipient is suitable for use in pharmaceutical products, though the specific drug or product name is not identified in this document excerpt.

FDA-2025-P-6625 · 8 docket documents

The law firm Hyman, Phelps & McNamara, P.C., filed a suitability petition on behalf of a client pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Metformin Hydrochloride Tablets at 375 mg strength suitable for submission in an Abbreviated New

FDA-2025-P-3438 · 8 docket documents

Hyman, Phelps & McNamara, P.C., on behalf of a client, submitted a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that FDA declare Metformin Hydrochloride Tablets, 250 mg, suitable for submission as an ANDA, with the reference listed drug being

FDA-2019-P-3877 · 4 docket documents

Harman Finochem Limited filed this citizen petition requesting that the FDA Commissioner confirm that Glucophage (metformin hydrochloride tablets), NDA 020357 held by Bristol Myers Squibb, was not withdrawn from sale for safety or effectiveness reasons, as required under 21 CFR 314.161 and 21 CFR 31

FDA-2019-P-2559 · 4 docket documents

Ajanta Pharma USA Inc filed this citizen petition requesting FDA confirmation that FORTAMET (metformin hydrochloride extended-release tablets 500 mg and 1 g), approved under NDA N021574 and held by Andrx Labs LLC, was voluntarily withdrawn from the market for reasons other than safety or effectivene

FDA-2002-P-0214 · 8 docket documents

The Weinberg Group Inc. filed this petition requesting that the FDA declare Metformin Hydrochloride Tablets for Oral Solution in 500 mg, 850 mg, and 1000 mg strengths suitable for submission as an ANDA under Section 505(j)(2)(c) of the Federal Food, Drug, and Cosmetic Act, with Glucophage metformin

FDA-2012-P-0826 · 3 docket documents

Lachman Consultant Services, Inc., on behalf of a client, filed a petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Sitagliptin and Metformin Hydrochloride Extended-release Tablets, 50 mg/850 mg suitable for consideration in an ANDA, with

FDA-2010-P-0533 · 5 docket documents

Zydus Pharmaceuticals USA, Inc. filed this suitability petition on September 30, 2010, pursuant to Section 505(j)(2)(c) of the Federal Food, Drug, and Cosmetic Act and 21 CFR § 314.93, requesting that the FDA declare Metformin Hydrochloride 500 mg, 850 mg, and 1 gm Powder for Solution suitable for s