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.
AFATINIB DIMALEATE | A210750 | HETERO LABS LTD V
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. et al v. HETERO USA INC. et al 1 patentANDA 210750afatinib | D.N.J. | 2017-10-05 | Terminated 2018-05-02 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.