METFORMIN HYDROCHLORIDE

FDA-2026-P-7602 · 6 docket documents

Senores Pharmaceuticals, Inc. filed this suitability petition 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 Tablets 375 mg and 425 mg suitable for submission in an ANDA, with the proposed strengths derived ari

FDA-2026-P-5991 · 8 docket documents

The law firm Hyman, Phelps & McNamara, P.C., filing on behalf of a client, submitted a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93, requesting that the FDA declare Metformin HCl Capsules in 250 mg, 500 mg, and 625 mg strengths sui

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-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confirm that Glucophage (metformin hydrochloride tablets), NDA 020357 held by Bristol Myers Squibb, was not withdrawn from sale for safety or effectiveness reasons, as required under 21 CFR 314.161 and 21 CFR 31