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.
TAPENTADOL | A204972 | ACTAVIS ELIZABETH
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
ASSERTIO THERAPEUTICS, INC. et al v. ACTAVIS ELIZABETH LLC 1 patentANDA 204972tapentadol hydrochloride | D.N.J. | 2015-09-11 | Terminated 2017-04-11 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.