Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202365
Company: WATSON LABS INC
Company: WATSON LABS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE | SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE | 50MG;500MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE | SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE | 50MG;1000MG | TABLET;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 |
---|---|---|---|---|---|---|---|
10/30/2015 | ORIG-1 | Tentative Approval |
Label is not available on this site. |