Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201189
Company: PADAGIS US
Company: PADAGIS US
| 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-2 | Approval | Not Applicable |
Label is not available on this site. |
|||
| 07/17/2013 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/28/2019 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/28/2019 | SUPPL-5 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 08/26/2013 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |