Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204144
Company: PH HEALTH
Company: PH HEALTH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE | 500MG;EQ 50MG BASE | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE | 1GM;EQ 50MG BASE | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE | 1GM;EQ 100MG BASE | TABLET, EXTENDED RELEASE;ORAL | Discontinued | 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 |
|---|---|---|---|---|---|---|---|
| 06/04/2025 | ORIG-1 | Approval |
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