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 | A213900 | AUROBINDO PHARMA LIMITED
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
MITSUBISHI TANABE PHARMA CORPORATION et al v. AUROBINDO PHARMA USA, INC. 2 patentsANDA 213900canagliflozin and metformin hydrochloride | D.N.J. | 2020-03-20 | Terminated 2020-07-17 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.