METOPROLOL TARTRATE | N017963 | VALIDUS PHARMACEUTICALS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Lachman Consulting Services, Inc. FDA-2025-P-2104 Lachman Consulting Services, Inc. filed this suitability petition on behalf of a client under Section 505(j)(2)(C) of the FD&C Act, requesting that the FDA declare Metoprolol Tartrate Tablets, 12.5 mg suitable for submission as an ANDA based on the reference listed drug LOPRESSOR (metoprolol tartrat | Suitability | 2025-07-03 | Open | Lachman Consulting Services |
Suitability Petition from Hyman, Phelps & McNamara P.C. FDA-2021-P-0124 On January 25, 2021, Hyman, Phelps & McNamara P.C. filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Metoprolol Tartrate Tablets, 12.5 mg, suitable for submission as an abbreviated new drug application (ANDA), with the | Suitability | 2021-01-28 | Open | Hyman |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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