METFORMIN HYDROCHLORIDE | N021202 | EMD SERONO INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Macleods Pharmaceuticals Limited FDA-2020-P-1792 Macleods Pharmaceuticals Limited filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate a suitable reference standard for metformin hydrochloride extended-release tablets 750 mg to support ANDA submissions, as the current refere | 505(q) | 2020-08-21 | Withdrawn | Macleods Pharmaceuticals Limited |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extended-release tablets 500 mg and 1 g), approved under NDA N021574 and held by Andrx Labs LLC, was voluntarily withdrawn from the market for reasons other than safety or effectivene | 505(q) | 2019-05-28 | Granted | Ajanta Pharma USA Inc |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 Hyman, Phelps & McNamara PC FDA-2018-P-3786 The law firm Hyman, Phelps & McNamara PC, on behalf of a client, submitted a petition pursuant to Federal Food, Drug, and Cosmetic Act section 505(j)(2)(C) requesting that the FDA determine that Metformin Hydrochloride 750 mg and Sitagliptin Phosphate Extended-Release Tablets 50 mg is suitable for s | Other | 2018-10-04 | Granted | Hyman, Phelps & McNamara PC |
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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