Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216885
Company: PRINSTON PHARMACEUTICAL INC
Company: PRINSTON PHARMACEUTICAL INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SITAGLIPTIN PHOSPHATE AND METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE | 1000MG | TABLET;FILM COATED | None (Tentative Approval) | None | No | No |
| SITAGLIPTIN PHOSPHATE AND METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE | 50MG | TABLET;FILM COATED | None (Tentative Approval) | None | No | No |
| SITAGLIPTIN PHOSPHATE AND METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE | 500MG | TABLET;FILM COATED | 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 |
|---|---|---|---|---|---|---|---|
| 03/13/2025 | ORIG-1 | Tentative Approval | STANDARD |
Label is not available on this site. |