Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203000
Company: ZYDUS LIFESCIENCES
Company: ZYDUS LIFESCIENCES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 12.5MG;80MG | TABLET;ORAL | Discontinued | None | No | No |
| VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 12.5MG;160MG | TABLET;ORAL | Discontinued | None | No | No |
| VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 12.5MG;320MG | TABLET;ORAL | Discontinued | None | No | No |
| VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 25MG;160MG | TABLET;ORAL | Discontinued | None | No | No |
| VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | 25MG;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 |
|---|---|---|---|---|---|---|---|
| 03/15/2019 | ORIG-1 | Approval |
Label is not available on this site. |