BUSPIRONE HYDROCHLORIDE | N021190 | BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Senores Pharmaceuticals, Inc FDA-2026-P-7195 Senores Pharmaceuticals, Inc. filed this suitability petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Buspirone Capsules in strengths of 2.5 mg, 12.5 mg, 20 mg, and 30 mg suitable for submission in an Abbreviated New Drug Applicati | Suitability | 2026-06-30 | Open | Senores Pharmaceuticals |
Citizen Petition from Epic Pharma LLC FDA-2023-P-0120 Epic Pharma, LLC submitted this petition under Section 505(j)(2)(C) of the FD&C Act to request that the FDA Commissioner determine whether Buspar (Buspirone Hydrochloride) Capsules 5 mg, 7.5 mg, 10 mg, and 15 mg, approved under NDA 021190 by Bristol Myers Squibb, were withdrawn from the market for s | 505(q) | 2023-01-12 | Granted | Epic Pharma LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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