Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090252
Company: MYLAN
Company: MYLAN
| 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 |
Label is not available on this site. |
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| 08/23/2013 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/03/2019 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/03/2019 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/07/2015 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |