Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217017
Company: ZHEJIANG JIUZHOU BIOPHARMA CO., LTD.
Company: ZHEJIANG JIUZHOU BIOPHARMA CO., LTD.
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE | 100MG/1000MG | TABLET, EXTENDED RELEASE | None (Tentative Approval) | None | No | No |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE | 50MG/1000MG | TABLET, EXTENDED RELEASE | None (Tentative Approval) | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/26/2025 | ORIG-1 | Tentative Approval | STANDARD |
Label is not available on this site. |