FDA.reportPublic FDA data

Application 203466

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDECANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDETABLET;ORAL16MG;12.5MGNoNo
002CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDECANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDETABLET;ORAL32MG;12.5MGNoNo
003CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDECANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDETABLET;ORAL32MG;25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-194candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-194candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-194candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-194candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-195candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-195candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-195candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-195candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-416candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-416candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-416candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-416candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1325candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideCadila Healthcare LimitedANDACurrent
70771-1325candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideCadila Healthcare LimitedANDACurrent
70771-1325candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideZydus Lifesciences LimitedANDACurrent
70771-1325candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideCadila Healthcare LimitedANDACurrent
70771-1326candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideCadila Healthcare LimitedANDACurrent
70771-1326candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideCadila Healthcare LimitedANDACurrent
70771-1326candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideZydus Lifesciences LimitedANDACurrent
70771-1326candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideCadila Healthcare LimitedANDACurrent
70771-1327candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideCadila Healthcare LimitedANDACurrent
70771-1327candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideCadila Healthcare LimitedANDACurrent
70771-1327candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideZydus Lifesciences LimitedANDACurrent
70771-1327candesartan cilexetil and hydrochlorothiazidecandesartan cilexetil and hydrochlorothiazideCadila Healthcare LimitedANDACurrent