METFORMIN HYDROCHLORIDE | N021574 | ANDRX LABS LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
SHIONOGI INC. et al v. NOSTRUM LABORATORIES, INC. et al 2 patentsANDA 203832metformin hydrochloride | D.N.J. | 2012-07-13 | Terminated 2013-05-03 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
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extended-release tablets 500 mg and 1 g), approved under NDA N021574 and held by Andrx Labs LLC, was voluntarily withdrawn from the market for reasons other than safety or effectivene | 505(q) | 2019-05-28 | Withdrawn | Ajanta Pharma USA Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.