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.
DEXTROMETHORPHAN HYDROBROMIDE;QUINIDINE SULFATE | A202993 | PAR PHARM INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Avanir Pharmaceuticals Inc. v. Par Pharmaceutical Inc. et al 1 patentANDA 202993dextromethorphan hydrobromide/quinidine sulfate | D. Del. | 2012-09-12 | Terminated 2015-09-25 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.