METFORMIN HYDROCHLORIDE | A090692 | LUPIN LTD
| 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extended-release tablets 500 mg and 1 g), approved under NDA N021574 and held by Andrx Labs LLC, was voluntarily withdrawn from the market for reasons other than safety or effectivene | 505(q) | 2019-05-28 | Withdrawn | Ajanta Pharma USA Inc |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.
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