FDA.reportPublic FDA data

Application 091390

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CANDESARTAN CILEXETILCANDESARTAN CILEXETILTABLET;ORAL4MGNoNo
002CANDESARTAN CILEXETILCANDESARTAN CILEXETILTABLET;ORAL8MGNoNo
003CANDESARTAN CILEXETILCANDESARTAN CILEXETILTABLET;ORAL16MGNoNo
004CANDESARTAN CILEXETILCANDESARTAN CILEXETILTABLET;ORAL32MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-190Candesartan cilexetilCandesartan cilexetilZydus Pharmaceuticals USA Inc.ANDACurrent
68382-190Candesartan cilexetilCandesartan cilexetilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-190Candesartan cilexetilCandesartan cilexetilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-191Candesartan cilexetilCandesartan cilexetilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-191Candesartan cilexetilCandesartan cilexetilZydus Pharmaceuticals USA Inc.ANDACurrent
68382-191Candesartan cilexetilCandesartan cilexetilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-192Candesartan cilexetilCandesartan cilexetilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-192Candesartan cilexetilCandesartan cilexetilZydus Pharmaceuticals USA Inc.ANDACurrent
68382-192Candesartan cilexetilCandesartan cilexetilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-193Candesartan cilexetilCandesartan cilexetilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-193Candesartan cilexetilCandesartan cilexetilZydus Pharmaceuticals USA Inc.ANDACurrent
68382-193Candesartan cilexetilCandesartan cilexetilZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1204Candesartan cilexetilCandesartan cilexetilCadila Healthcare LimitedANDACurrent
70771-1204Candesartan cilexetilCandesartan cilexetilCadila Healthcare LimitedANDACurrent
70771-1204Candesartan cilexetilCandesartan cilexetilZydus Lifesciences LimitedANDACurrent
70771-1204Candesartan cilexetilCandesartan cilexetilCadila Healthcare LimitedANDACurrent
70771-1205Candesartan cilexetilCandesartan cilexetilCadila Healthcare LimitedANDACurrent
70771-1205Candesartan cilexetilCandesartan cilexetilZydus Lifesciences LimitedANDACurrent
70771-1205Candesartan cilexetilCandesartan cilexetilCadila Healthcare LimitedANDACurrent
70771-1205Candesartan cilexetilCandesartan cilexetilCadila Healthcare LimitedANDACurrent
70771-1206Candesartan cilexetilCandesartan cilexetilCadila Healthcare LimitedANDACurrent
70771-1206Candesartan cilexetilCandesartan cilexetilZydus Lifesciences LimitedANDACurrent
70771-1206Candesartan cilexetilCandesartan cilexetilCadila Healthcare LimitedANDACurrent
70771-1206Candesartan cilexetilCandesartan cilexetilCadila Healthcare LimitedANDACurrent
70771-1207Candesartan cilexetilCandesartan cilexetilCadila Healthcare LimitedANDACurrent
70771-1207Candesartan cilexetilCandesartan cilexetilZydus Lifesciences LimitedANDACurrent
70771-1207Candesartan cilexetilCandesartan cilexetilCadila Healthcare LimitedANDACurrent
70771-1207Candesartan cilexetilCandesartan cilexetilCadila Healthcare LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49579ORIG2017-08-29