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.
CANAGLIFLOZIN;METFORMIN HYDROCHLORIDE | A210542 | ZYDUS PHARMS USA INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
MITSUBISHI TANABE PHARMA CORPORATION et al v. SANDOZ INC. et al 3 patentsANDA 210297, 210481, 210541, 210542canagliflozin and canagliflozin and metformin hydrochloride | D.N.J. | 2017-07-20 | Terminated 2021-04-05 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.