FDA.reportPublic FDA data

Application 203000

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTANTABLET;ORAL12.5MG;80MGNoNo
002VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTANTABLET;ORAL12.5MG;160MGNoNo
003VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTANTABLET;ORAL12.5MG;320MGNoNo
004VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTANTABLET;ORAL25MG;160MGNoNo
005VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTANTABLET;ORAL25MG;320MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-279valsartan and hydrochlorothiazidevalsartan and hydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-279valsartan and hydrochlorothiazidevalsartan and hydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-280valsartan and hydrochlorothiazidevalsartan and hydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-280valsartan and hydrochlorothiazidevalsartan and hydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-281valsartan and hydrochlorothiazidevalsartan and hydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-281valsartan and hydrochlorothiazidevalsartan and hydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-282valsartan and hydrochlorothiazidevalsartan and hydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-282valsartan and hydrochlorothiazidevalsartan and hydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-283valsartan and hydrochlorothiazidevalsartan and hydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-283valsartan and hydrochlorothiazidevalsartan and hydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1485valsartan and hydrochlorothiazidevalsartan and hydrochlorothiazideZydus Lifesciences LimitedANDACurrent
70771-1485valsartan and hydrochlorothiazidevalsartan and hydrochlorothiazideCadila Healthcare LimitedANDACurrent
70771-1485valsartan and hydrochlorothiazidevalsartan and hydrochlorothiazideCadila Healthcare LimitedANDACurrent
70771-1486valsartan and hydrochlorothiazidevalsartan and hydrochlorothiazideCadila Healthcare LimitedANDACurrent
70771-1486valsartan and hydrochlorothiazidevalsartan and hydrochlorothiazideCadila Healthcare LimitedANDACurrent
70771-1486valsartan and hydrochlorothiazidevalsartan and hydrochlorothiazideZydus Lifesciences LimitedANDACurrent
70771-1487valsartan and hydrochlorothiazidevalsartan and hydrochlorothiazideCadila Healthcare LimitedANDACurrent
70771-1487valsartan and hydrochlorothiazidevalsartan and hydrochlorothiazideCadila Healthcare LimitedANDACurrent
70771-1487valsartan and hydrochlorothiazidevalsartan and hydrochlorothiazideZydus Lifesciences LimitedANDACurrent
70771-1488valsartan and hydrochlorothiazidevalsartan and hydrochlorothiazideCadila Healthcare LimitedANDACurrent
70771-1488valsartan and hydrochlorothiazidevalsartan and hydrochlorothiazideCadila Healthcare LimitedANDACurrent
70771-1488valsartan and hydrochlorothiazidevalsartan and hydrochlorothiazideZydus Lifesciences LimitedANDACurrent
70771-1489valsartan and hydrochlorothiazidevalsartan and hydrochlorothiazideCadila Healthcare LimitedANDACurrent
70771-1489valsartan and hydrochlorothiazidevalsartan and hydrochlorothiazideCadila Healthcare LimitedANDACurrent
70771-1489valsartan and hydrochlorothiazidevalsartan and hydrochlorothiazideZydus Lifesciences LimitedANDACurrent