SPIRONOLACTONE | N012151 | PFIZER INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Pharmobedient Consulting, LLC FDA-2025-P-1029 Pharmobedient Consulting, LLC filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Spironolactone Tablets, 12.5 mg suitable for submission in an Abbreviated New Drug Application, with the reference listed drug being Pf | Suitability | 2025-04-03 | Open | Pharmobedient Consulting |
Suitability Petition from Lachman Consulting Services, Inc. FDA-2025-P-0509 Lachman Consulting Services, Inc. filed this suitability petition under Section 505(j)(2)(C) of the FDC Act requesting that the FDA declare Spironolactone Tablets, 12.5 mg suitable for submission as an ANDA, with ALDACTONE (spironolactone) Tablets under NDA N012151 as the reference listed drug. The | Suitability | 2025-03-03 | Open | Lachman Consulting Services |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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