Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091654
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

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