PIMOZIDE | N017473 | TEVA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition Amendment from Senores Phamraceuticals FDA-2026-P-0748 Senores Pharmaceuticals filed a Suitability Petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 CFR 314.93 requesting FDA authorization to submit an Abbreviated New Drug Application for Bupropion Hydrochloride Tablets 150 mg, a strength differing from the ref | Suitability | 2026-02-09 | Open | — |
Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2025-P-2148 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 Pimozide Tablets 0.5 mg suitable for submission in an Abbreviated New Drug Application, with the reference listed drug being pimo | Suitability | 2025-07-07 | Open | Senores Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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