Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204144
Company: ANCHEN PHARMS
Company: ANCHEN PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE | METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE | 500MG; EQ 50MG BASE | TABLET, EXTENDED RELEASE;ORAL | None (Tentative Approval) | None | No | No |
| METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE | METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE | 1GM; EQ 50MG BASE | TABLET, EXTENDED RELEASE;ORAL | None (Tentative Approval) | None | No | No |
| METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE | METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE | 1GM; EQ 100MG BASE | TABLET, EXTENDED RELEASE;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 04/21/2015 | ORIG-1 | Tentative Approval |
Label is not available on this site. |