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 | WVND | 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 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(bupropion hydrochloride sustained-release tablets, 150 mg) under NDA 020711 held by GlaxoSmithKline was voluntarily withdrawn from comm | 505(q) | 2022-04-19 | Denied | Yichang Humanwell Pharmaceutical Co. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.