FDA.reportPublic FDA data

Application 204221

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TELMISARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TELMISARTANTABLET;ORAL12.5MG;40MGNoNo
002TELMISARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TELMISARTANTABLET;ORAL12.5MG;80MGNoNo
003TELMISARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TELMISARTANTABLET;ORAL25MG;80MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-513Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-513Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-513Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-513Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-514Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-514Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-514Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-514Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-515Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-515Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-515Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-515Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideZydus Pharmaceuticals USA Inc.ANDACurrent
70771-1123Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideCadila Healthcare LimitedANDACurrent
70771-1123Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideCadila Healthcare LimitedANDACurrent
70771-1123Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideCadila Healthcare LimitedANDACurrent
70771-1123Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideZydus Lifesciences LimitedANDACurrent
70771-1124Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideCadila Healthcare LimitedANDACurrent
70771-1124Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideZydus Lifesciences LimitedANDACurrent
70771-1124Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideCadila Healthcare LimitedANDACurrent
70771-1124Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideCadila Healthcare LimitedANDACurrent
70771-1125Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideCadila Healthcare LimitedANDACurrent
70771-1125Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideZydus Lifesciences LimitedANDACurrent
70771-1125Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideCadila Healthcare LimitedANDACurrent
70771-1125Telmisartan and HydrochlorothiazideTelmisartan and HydrochlorothiazideCadila Healthcare LimitedANDACurrent