FDA.reportPublic FDA data

Application 207761

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NADOLOLNADOLOLTABLET;ORAL20MGNoNo
002NADOLOLNADOLOLTABLET;ORAL40MGNoNo
003NADOLOLNADOLOLTABLET;ORAL80MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-732NadololNadololZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-732NadololNadololZydus Pharmaceuticals USA Inc.ANDACurrent
68382-732NadololNadololZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-732NadololNadololZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-733NadololNadololZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-733NadololNadololZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-733NadololNadololZydus Pharmaceuticals USA Inc.ANDACurrent
68382-733NadololNadololZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-734NadololNadololZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-734NadololNadololZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-734NadololNadololZydus Pharmaceuticals USA Inc.ANDACurrent
68382-734NadololNadololZydus Pharmaceuticals (USA) Inc.ANDACurrent
70518-2139NadololNadololREMEDYREPACK INC.ANDACurrent
70518-2139NadololNadololREMEDYREPACK INC.ANDACurrent
70518-2139NadololNadololREMEDYREPACK INC.ANDACurrent
70771-1089NadololNadololZydus Lifesciences LimitedANDACurrent
70771-1089NadololNadololCadila Healthcare LimitedANDACurrent
70771-1089NadololNadololCadila Healthcare LimitedANDACurrent
70771-1089NadololNadololCadila Healthcare LimitedANDACurrent
70771-1090NadololNadololZydus Lifesciences LimitedANDACurrent
70771-1090NadololNadololCadila Healthcare LimitedANDACurrent
70771-1090NadololNadololCadila Healthcare LimitedANDACurrent
70771-1090NadololNadololCadila Healthcare LimitedANDACurrent
70771-1091NadololNadololZydus Lifesciences LimitedANDACurrent
70771-1091NadololNadololCadila Healthcare LimitedANDACurrent
70771-1091NadololNadololCadila Healthcare LimitedANDACurrent
70771-1091NadololNadololCadila Healthcare LimitedANDACurrent
71335-0697NadololNadololBryant Ranch PrepackANDACurrent
71335-0697NadololNadololBryant Ranch PrepackANDACurrent
71335-0697NadololNadololBryant Ranch PrepackANDACurrent
71335-0697NadololNadololBryant Ranch PrepackANDACurrent