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.
DIENOGEST; ESTRADIOL VALERATE | A202349 | WATSON LABS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Bayer Pharma AG et al v. Watson Laboratories Inc. 1 patentANDA 202349estradiol valerate and dienogest | D. Del. | 2012-12-18 | Terminated 2016-12-28 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.