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.
DRONEDARONE HYDROCHLORIDE | A205895 | ALKEM LABS LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2015-12-23 | Terminated 2017-11-07 | — | |
Sanofi et al v. Alkem Laboratories, Ltd. et al 4 patentsANDA 205895Dronedarone Hydrochloride | N.D. Ill. | 2014-03-19 | Terminated 2014-05-15 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.