Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209261
Company: UNICHEM
Company: UNICHEM
| 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 |
|---|---|---|---|---|---|---|---|
| 05/04/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/22/2024 | SUPPL-6 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/22/2024 | SUPPL-5 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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| 08/20/2019 | SUPPL-2 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |