Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201677
Company: LUPIN
Company: LUPIN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VALSARTAN | VALSARTAN | 40MG | TABLET;ORAL | Discontinued | None | No | No |
| VALSARTAN | VALSARTAN | 80MG | TABLET;ORAL | Discontinued | None | No | No |
| VALSARTAN | VALSARTAN | 160MG | TABLET;ORAL | Discontinued | None | No | No |
| VALSARTAN | VALSARTAN | 320MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/05/2015 | 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 |
|---|---|---|---|---|---|
| 09/03/2019 | SUPPL-4 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/03/2019 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/20/2015 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |