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.
TRIFLURIDINE; TIPIRACIL | A214036 | INTAS PHARMS LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Taiho Pharmaceutical Co., Ltd. et al v. MSN Laboratories Private Ltd. et al 1 patentANDA 214036trifluridine and tipiracil | D. Del. | 2021-06-09 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.