METFORMIN HYDROCHLORIDE | N020357 | EMD SERONO INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-5991 Hyman, Phelps & McNamara, P.C., on behalf of an unnamed client, filed this suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93 requesting that FDA declare Metformin HCl Capsules in 250 mg, 500 mg, and 625 mg strengths suitable for s | Suitability | 2026-05-27 | Open | Hyman |
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 |
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 | Open | Hyman |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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