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.
VARDENAFIL HYDROCHLORIDE | A203689 | WATSON LABS TEVA
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Bayer Pharma AG et al v. Watson Laboratories, Inc. 2 patentsANDA 203689vardenafil hydrochloride | D. Del. | 2012-04-25 | Terminated 2016-05-02 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.