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.
CABAZITAXEL | N207937 | FRESENIUS KABI USA
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Sanofi-Aventis U.S. LLC, et al. v. Sandoz Inc. 2 patentsANDA 207736, 207619, 207718, 207591cabazitaxel | D. Del. | 2020-06-12 | Terminated 2023-07-05 | — |
| D.N.J. | 2014-12-17 | Terminated 2018-03-05 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.