Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090008
Company: ACTAVIS TOTOWA
Company: ACTAVIS TOTOWA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| REPAGLINIDE | REPAGLINIDE | 0.5MG | TABLET;ORAL | Discontinued | None | No | No |
| REPAGLINIDE | REPAGLINIDE | 1MG | TABLET;ORAL | Discontinued | None | No | No |
| REPAGLINIDE | REPAGLINIDE | 2MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 01/22/2014 | ORIG-1 | Approval |
Label is not available on this site. |