BUPROPION HYDROCHLORIDE | N020711 | GLAXOSMITHKLINE
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Indivior Inc. et al v. Mylan Technologies Inc. et al 1 patentANDA 207259buprenorphine hydrochloride and naloxone hydrochloride | N.D. W. Va. | 2017-09-14 | Terminated 2017-09-27 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Yichang Humanwell Pharmaceutical Co., Ltd. FDA-2022-P-0614 · 7 docket documents Yichang Humanwell Pharmaceutical Co., Ltd. filed this citizen petition on April 18, 2022, requesting that the FDA determine whether the reference listed drug ZYBAN (bupropion hydrochloride sustained-release tablets, 150 mg) under NDA 020711 held by GlaxoSmithKline was voluntarily withdrawn from comm | 505(q) | 2022-04-19 | Granted | Yichang Humanwell Pharmaceutical Co., Ltd. |
Valeant Pharmaceuticals International, Inc. (Covington & Burling) - Citizen P... FDA-2012-P-1091 · 4 docket documents 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 · 7 docket documents 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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