Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.
NALTREXONE HYDROCHLORIDE;BUPROPION HYDROCHLORIDE | A208043 | ACTAVIS LABS FL INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Nalpropion Pharmaceuticals, Inc. v. Actavis Laboratories FL, Inc.. 7 patentsANDA 208043Naltrexone Hydrochloride and Bupropion Hydrochloride | D. Del. | 2015-06-03 | Terminated 2020-10-20 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.