Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091654
Company: TORRENT PHARMS LTD
Company: TORRENT PHARMS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VALSARTAN; HYDROCHLOROTHIAZIDE | VALSARTAN; HYDROCHLOROTHIAZIDE | 80MG; 12.5MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
VALSARTAN; HYDROCHLOROTHIAZIDE | VALSARTAN; HYDROCHLOROTHIAZIDE | 160MG; 12.5MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
VALSARTAN; HYDROCHLOROTHIAZIDE | VALSARTAN; HYDROCHLOROTHIAZIDE | 160MG; 25MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
VALSARTAN; HYDROCHLOROTHIAZIDE | VALSARTAN; HYDROCHLOROTHIAZIDE | 320MG; 12.5MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
VALSARTAN; HYDROCHLOROTHIAZIDE | VALSARTAN; HYDROCHLOROTHIAZIDE | 320MG; 25MG | TABLET; ORAL | None (Tentative Approval) | 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 |
---|---|---|---|---|---|---|---|
04/10/2012 | ORIG-1 | Tentative Approval |
Label is not available on this site. |