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.
ASPIRIN;OMEPRAZOLE | A209791 | TEVA PHARMS USA INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Aralez Pharmaceuticals Inc. et al v. Teva Pharmaceuticals USA, Inc. et al 4 patentsANDA 209791aspirin and omeprazole | E.D. Tex. | 2017-01-23 | Terminated 2017-10-30 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.