FDA.reportPublic FDA data

Application 202332

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDETABLET, EXTENDED RELEASE;ORAL5MGNoNo
002OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDETABLET, EXTENDED RELEASE;ORAL10MGNoNo
003OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDETABLET, EXTENDED RELEASE;ORAL15MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8219oxybutyninoxybutyninNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8220OxybutyninOxybutyninNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
50090-5352oxybutyninoxybutyninA-S Medication SolutionsANDACurrent
50090-5352oxybutyninoxybutyninA-S Medication SolutionsANDACurrent
50090-5353oxybutyninoxybutyninA-S Medication SolutionsANDACurrent
50090-5353oxybutyninoxybutyninA-S Medication SolutionsANDACurrent
68382-255oxybutyninoxybutyninZydus Pharmaceuticals USA Inc.ANDACurrent
68382-255oxybutyninoxybutyninZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-255oxybutyninoxybutyninZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-255oxybutyninoxybutyninZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-255oxybutyninoxybutyninZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-256oxybutyninoxybutyninZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-256oxybutyninoxybutyninZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-256oxybutyninoxybutyninZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-256oxybutyninoxybutyninZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-256oxybutyninoxybutyninZydus Pharmaceuticals USA Inc.ANDACurrent
68382-257oxybutyninoxybutyninZydus Pharmaceuticals USA Inc.ANDACurrent
68382-257oxybutyninoxybutyninZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-257oxybutyninoxybutyninZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-257oxybutyninoxybutyninZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-257oxybutyninoxybutyninZydus Pharmaceuticals (USA) Inc.ANDACurrent
70518-1457oxybutyninoxybutyninREMEDYREPACK INC.ANDACurrent
70518-1457oxybutyninoxybutyninREMEDYREPACK INC.ANDACurrent
70518-2331oxybutyninoxybutyninREMEDYREPACK INC.ANDACurrent
70771-1086oxybutyninoxybutyninCadila Healthcare LimitedANDACurrent
70771-1086oxybutyninoxybutyninCadila Healthcare LimitedANDACurrent
70771-1086oxybutyninoxybutyninCadila Healthcare LimitedANDACurrent
70771-1086oxybutyninoxybutyninCadila Healthcare LimitedANDACurrent
70771-1086oxybutyninoxybutyninZydus Lifesciences LimitedANDACurrent
70771-1087oxybutyninoxybutyninCadila Healthcare LimitedANDACurrent
70771-1087oxybutyninoxybutyninZydus Lifesciences LimitedANDACurrent
70771-1087oxybutyninoxybutyninCadila Healthcare LimitedANDACurrent
70771-1087oxybutyninoxybutyninCadila Healthcare LimitedANDACurrent
70771-1087oxybutyninoxybutyninCadila Healthcare LimitedANDACurrent
70771-1088oxybutyninoxybutyninCadila Healthcare LimitedANDACurrent
70771-1088oxybutyninoxybutyninCadila Healthcare LimitedANDACurrent
70771-1088oxybutyninoxybutyninCadila Healthcare LimitedANDACurrent
70771-1088oxybutyninoxybutyninCadila Healthcare LimitedANDACurrent
70771-1088oxybutyninoxybutyninZydus Lifesciences LimitedANDACurrent
71335-0974oxybutyninoxybutyninBryant Ranch PrepackANDACurrent
71335-0974oxybutyninoxybutyninBryant Ranch PrepackANDACurrent
71335-0974oxybutyninoxybutyninBryant Ranch PrepackANDACurrent