METFORMIN HYDROCHLORIDE | A090564 | GRANULES INDIA LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Senores Pharmaceuticals, Inc 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 C.F.R. § 314.93, requesting that the FDA declare Metformin Tablets 375 mg and 425 mg suitable for submission in an Abbreviated New Drug Application, with | Suitability | 2026-07-08 | Open | Senores Pharmaceuticals, Inc |
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-5991 · 8 docket documents The law firm Hyman, Phelps & McNamara, P.C. filed this suitability petition under Federal Food, Drug and Cosmetic Act section 505(j)(2)(C) and 21 CFR 314.93 requesting that the FDA declare Metformin HCl Capsules in 250 mg, 500 mg, and 625 mg strengths suitable for submission as an ANDA, with the ref | Suitability | 2026-05-27 | Open | Hyman, Phelps & McNamara, P.C. |
Suitability Petition from Hyman, Phelps & McNamara, P.C. 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 | Suitability | 2025-12-03 | Open | Hyman, Phelps & McNamara, P.C. |
Citizen Petition from Harman Finochem Limited 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confirm that Glucophage (metformin hydrochloride tablets), NDA 020357 held by Bristol Myers Squibb, was not withdrawn from sale for safety or effectiveness reasons, as required under 21 CFR 314.161 and 21 CFR 31 | 505(q) | 2019-08-20 | Granted | Harman Finochem Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.0247
per ea
Lowest NADAC/Unit
$0.0140
per ea
Brand NDCs
0
Generic NDCs
31
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 70010006410METFORMIN HCL 850 MG TABLET | $0.0247 | EA | Generic | — | 2026-06-17 |
| 70010006499METFORMIN HCL 850 MG TABLET | $0.0247 | EA | Generic | — | 2026-06-17 |
| 00904716361METFORMIN HCL 850 MG TABLET | $0.0247 | EA | Generic | — | 2026-06-17 |
| 68645058359METFORMIN HCL 850 MG TABLET | $0.0247 | EA | Generic | — | 2026-06-17 |
| 67877056210METFORMIN HCL 850 MG TABLET | $0.0247 | EA | Generic | — | 2026-06-17 |
| 67877056205METFORMIN HCL 850 MG TABLET | $0.0247 | EA | Generic | — | 2026-06-17 |
Showing 6 of 31 NDCs.
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.