FDA.reportPublic FDA data

Application 205936

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SPIRONOLACTONESPIRONOLACTONETABLET;ORAL25MGNoNo
002SPIRONOLACTONESPIRONOLACTONETABLET;ORAL50MGNoNo
003SPIRONOLACTONESPIRONOLACTONETABLET;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6927spironolactonespironolactoneMajor PharmaceuticalsANDACurrent
0904-6927spironolactonespironolactoneMajor PharmaceuticalsANDACurrent
55154-3556spironolactonespironolactoneCardinal Health 107, LLCANDACurrent
55700-713spironolactonespironolactoneQuality Care Products, LLCANDACurrent
55700-713spironolactonespironolactoneQuality Care Products, LLCANDACurrent
55700-934spironolactonespironolactoneQuality Care Products, LLCANDACurrent
60687-465SpironolactoneSpironolactoneAmerican Health PackagingANDACurrent
60687-465SpironolactoneSpironolactoneAmerican Health PackagingANDACurrent
60687-465SpironolactoneSpironolactoneAmerican Health PackagingANDACurrent
60687-476SpironolactoneSpironolactoneAmerican Health PackagingANDACurrent
60687-476SpironolactoneSpironolactoneAmerican Health PackagingANDACurrent
60687-476SpironolactoneSpironolactoneAmerican Health PackagingANDACurrent
60687-487SpironolactoneSpironolactoneAmerican Health PackagingANDACurrent
60687-487SpironolactoneSpironolactoneAmerican Health PackagingANDACurrent
60687-487SpironolactoneSpironolactoneAmerican Health PackagingANDACurrent
67296-1692spironolactonespironolactoneRedPharm Drug, Inc.ANDACurrent
67296-1692spironolactonespironolactoneRedPharm Drug, Inc.ANDACurrent
68382-660spironolactonespironolactoneZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-660spironolactonespironolactoneZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-660spironolactonespironolactoneZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-660spironolactonespironolactoneZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-660spironolactonespironolactoneZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-661spironolactonespironolactoneZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-661spironolactonespironolactoneZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-661spironolactonespironolactoneZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-661spironolactonespironolactoneZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-661spironolactonespironolactoneZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-662spironolactonespironolactoneZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-662spironolactonespironolactoneZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-662spironolactonespironolactoneZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-662spironolactonespironolactoneZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-662spironolactonespironolactoneZydus Pharmaceuticals (USA) Inc.ANDACurrent
70518-2384spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2384spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2384spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2385spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2385spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2385spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2386spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2386spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2386spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2585spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2585spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2585spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2585spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2585spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2588spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2588spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2588spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2588spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2589spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2589spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2589spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2589spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70518-2589spironolactonespironolactoneREMEDYREPACK INC.ANDACurrent
70771-1027spironolactonespironolactoneCadila Healthcare LimitedANDACurrent
70771-1027spironolactonespironolactoneCadila Healthcare LimitedANDACurrent
70771-1027spironolactonespironolactoneCadila Healthcare LimitedANDACurrent
70771-1027spironolactonespironolactoneZydus Lifesciences LimitedANDACurrent
70771-1027spironolactonespironolactoneCadila Healthcare LimitedANDACurrent
70771-1028spironolactonespironolactoneCadila Healthcare LimitedANDACurrent
70771-1028spironolactonespironolactoneCadila Healthcare LimitedANDACurrent
70771-1028spironolactonespironolactoneZydus Lifesciences LimitedANDACurrent
70771-1028spironolactonespironolactoneCadila Healthcare LimitedANDACurrent
70771-1028spironolactonespironolactoneCadila Healthcare LimitedANDACurrent
70771-1029spironolactonespironolactoneCadila Healthcare LimitedANDACurrent
70771-1029spironolactonespironolactoneCadila Healthcare LimitedANDACurrent
70771-1029spironolactonespironolactoneCadila Healthcare LimitedANDACurrent
70771-1029spironolactonespironolactoneZydus Lifesciences LimitedANDACurrent
70771-1029spironolactonespironolactoneCadila Healthcare LimitedANDACurrent
71335-1546spironolactonespironolactoneBryant Ranch PrepackANDACurrent
71335-1546spironolactonespironolactoneBryant Ranch PrepackANDACurrent
71335-1546spironolactonespironolactoneBryant Ranch PrepackANDACurrent
71335-1546spironolactonespironolactoneBryant Ranch PrepackANDACurrent
71335-1546spironolactonespironolactoneBryant Ranch PrepackANDACurrent
71335-1586spironolactonespironolactoneBryant Ranch PrepackANDACurrent
71335-1586spironolactonespironolactoneBryant Ranch PrepackANDACurrent
71335-1586spironolactonespironolactoneBryant Ranch PrepackANDACurrent
71335-1604spironolactonespironolactoneBryant Ranch PrepackANDACurrent
71335-1604spironolactonespironolactoneBryant Ranch PrepackANDACurrent