Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215411
Company: INVENTIA HEALTHCARE LIMITED
Company: INVENTIA HEALTHCARE LIMITED
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE | SITAGLIPTIN, METFORMIN HYDROCHLORIDE | 1000MG | TABLET | None (Tentative Approval) | None | No | No |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE | SITAGLIPTIN, METFORMIN HYDROCHLORIDE | 50MG | TABLET | None (Tentative Approval) | None | No | No |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE | SITAGLIPTIN, METFORMIN HYDROCHLORIDE | 500MG | TABLET | 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 |
|---|---|---|---|---|---|---|---|
| 05/07/2026 | ORIG-1 | Tentative Approval | STANDARD |
Label is not available on this site. |