BUPROPION HYDROCHLORIDE | A076143 | APOTEX INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2026-P-0748 Senores Pharmaceuticals, Inc. filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Bupropion Hydrochloride Tablets 150 mg suitable for submission in an ANDA, as the proposed strength differs from the reference listed d | Suitability | 2026-01-26 | Open | Senores Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.