BUSPIRONE HYDROCHLORIDE | A210907 | UNICHEM LABORATORIES LTD
| 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 |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.