BUPROPION HYDROCHLORIDE | N018644 | GLAXOSMITHKLINE
| 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-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 |
Citizen Petition from Catalyst Pharmaceuticals FDA-2021-P-0559 Catalyst Pharmaceuticals filed this citizen petition pursuant to Section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA require blinded, controlled randomized clinical trials as evidence of efficacy and safety for any new drug application or supplement for amifampridine inte | 505(q) | 2021-07-07 | Withdrawn | Catalyst Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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