METFORMIN HYDROCHLORIDE | N020357 | EMD SERONO INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Senores Pharmaceuticals, Inc FDA-2026-P-7602 Senores Pharmaceuticals, Inc filed a suitability petition requesting that the FDA determine whether a specific drug substance or excipient is suitable for use in pharmaceutical products. The petition seeks FDA guidance on the regulatory acceptability and specifications for the substance to support t | Suitability | 2026-07-08 | Open | Senores Pharmaceuticals, Inc |
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-5991 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. | Suitability | 2026-05-27 | Open | Hyman, Phelps & McNamara, P.C. |
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2025-P-6625 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 | Suitability | 2025-12-03 | Open | Hyman, Phelps & McNamara, P.C. |
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2025-P-3438 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 | Suitability | 2025-08-29 | Granted | Hyman, Phelps & McNamara, P.C. |
Citizen Petition from Harman Finochem Limited FDA-2019-P-3877 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confirm that Glucophage (metformin hydrochloride tablets), NDA 020357 held by Bristol Myers Squibb, was not withdrawn from sale for safety or effectiveness reasons, as required under 21 CFR 314.161 and 21 CFR 31 | 505(q) | 2019-08-20 | Granted | Harman Finochem Limited |
Citizen Petition from Ajanta Pharma USA Inc FDA-2019-P-2559 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 | 505(q) | 2019-05-28 | Granted | Ajanta Pharma USA Inc |
Citizen Petition from The Weinberg Group Inc. FDA-2002-P-0214 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 | Other | 2017-11-29 | Granted | The Weinberg Group Inc. |
Lachman Consultant Services Inc. - Citizen Petition FDA-2012-P-0826 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 | Other | 2012-09-06 | Denied | — |
Zydus Pharmaceuticals USA, Inc. - Citizen Petition FDA-2010-P-0533 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 | Other | 2010-10-14 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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