METFORMIN HYDROCHLORIDE | N212595 | SUN PHARMACEUTICAL INDUSTRIES LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-4535 Hyman, Phelps & McNamara, P.C., on behalf of a client, submitted this 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 for Extended-Release Oral Suspension in 500 mg and 750 mg unit-dose sa | Suitability | 2026-04-23 | Open | Hyman |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 9962336 | May 1, 2035 | — | — | Yes | — | — |