BUSPIRONE HYDROCHLORIDE | N018731 | BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-2302 The law firm Hyman, Phelps & McNamara filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93 requesting that the FDA declare Buspirone Tablets, 20 mg, suitable for submission as an Abbreviated New Drug Application, with BUSPAR (bu | Suitability | 2026-03-05 | Open | Hyman |
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2025-P-6524 The law firm Hyman, Phelps & McNamara, P.C., on behalf of a client, filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Buspirone HCl Oral Solution, 2 mg/mL, suitable for submission as an Abbreviated New Drug Applicati | Suitability | 2025-11-28 | Open | Hyman |
Suitability Petition from HYMAN, PHELPS & MCNAMARA P.C. FDA-2024-P-0545 Hyman, Phelps & McNamara P.C., on behalf of a client, filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Buspirone HCl Oral Solution, 2 mg/mL, suitable for submission as an Abbreviated New Drug Application, with the refe | Suitability | 2024-01-30 | Open | HYMAN |
Citizen Petition from Epic Pharma, LLC FDA-2022-P-1039 Epic Pharma, LLC submitted this citizen petition on June 7, 2022, pursuant to section 505(j)(2)(C) of the FD&C Act requesting FDA approval to file an Abbreviated New Drug Application for Buspirone Hydrochloride Tablets, USP in new strengths of 2.5 mg, 3.75 mg, and 12.5 mg, based on the reference lis | Other | 2022-06-07 | Granted | Epic Pharma |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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