FDA.reportPublic FDA data

Application 206693

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TADALAFILTADALAFILTABLET;ORAL2.5MGNoNo
002TADALAFILTADALAFILTABLET;ORAL5MGNoNo
003TADALAFILTADALAFILTABLET;ORAL10MGNoNo
004TADALAFILTADALAFILTABLET;ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4753TadalafilTadalafilA-S Medication SolutionsANDACurrent
50090-4753TadalafilTadalafilA-S Medication SolutionsANDACurrent
68382-896TadalafilTadalafilZydus Pharmaceuticals USA Inc.ANDACurrent
68382-896TadalafilTadalafilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-896TadalafilTadalafilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-897TadalafilTadalafilZydus Pharmaceuticals USA Inc.ANDACurrent
68382-897TadalafilTadalafilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-897TadalafilTadalafilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-898TadalafilTadalafilZydus Pharmaceuticals USA Inc.ANDACurrent
68382-898TadalafilTadalafilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-898TadalafilTadalafilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-899TadalafilTadalafilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-899TadalafilTadalafilZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-899TadalafilTadalafilZydus Pharmaceuticals USA Inc.ANDACurrent
70771-1475TadalafilTadalafilZydus Lifesciences LimitedANDACurrent
70771-1475TadalafilTadalafilCadila Healthcare LimitedANDACurrent
70771-1475TadalafilTadalafilCadila Healthcare LimitedANDACurrent
70771-1476TadalafilTadalafilZydus Lifesciences LimitedANDACurrent
70771-1476TadalafilTadalafilCadila Healthcare LimitedANDACurrent
70771-1476TadalafilTadalafilCadila Healthcare LimitedANDACurrent
70771-1477TadalafilTadalafilZydus Lifesciences LimitedANDACurrent
70771-1477TadalafilTadalafilCadila Healthcare LimitedANDACurrent
70771-1477TadalafilTadalafilCadila Healthcare LimitedANDACurrent
70771-1478TadalafilTadalafilZydus Lifesciences LimitedANDACurrent
70771-1478TadalafilTadalafilCadila Healthcare LimitedANDACurrent
70771-1478TadalafilTadalafilCadila Healthcare LimitedANDACurrent