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 | A205015 | ALKEM LABS LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Allkem Laboratories Limited v. NPS Pharmaceuticals, Inc 1 patentANDA 205015, 205016tapentadol | N.D. Ill. | 2013-09-10 | Terminated 2013-11-04 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.