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 | Granted | — |
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 | Granted | Senores Pharmaceuticals, Inc. |
Valeant Pharmaceuticals International, Inc. (Covington & Burling) - Citizen P... FDA-2012-P-1091 Valeant Pharmaceuticals International, Inc. filed this citizen petition on October 31, 2012, requesting that the FDA Commissioner withdraw approval of generic bupropion hydrochloride extended-release 300 mg products manufactured by Anchen (ANDA 77-284), Watson (ANDA 77-715), Actavis (ANDA 77-285), a | 505(q) | 2012-11-01 | Partially Denied | — |
Citizen Petition from Keller and Heckman LLP on behalf of Biovail Corporation FDA-2005-P-0366 Keller and Heckman LLP, on behalf of Biovail Corporation, submitted this citizen petition under 21 C.F.R. § 10.30 and section 505(j) of the FDC Act requesting that the FDA require generic versions of Wellbutrin XL (bupropion hydrochloride extended-release tablets) to meet specified bioequivalence cr | 505(q) | 2010-03-17 | Granted | Biovail Corporation |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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