FDA.reportPublic FDA data

Application 207138

Type
ANDA
Sponsor
ACCORD HLTHCARE

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;ORAL15MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16729-317oxybutynin chlorideoxybutynin chlorideAccord Healthcare, Inc.ANDACurrent
16729-317oxybutynin chlorideoxybutynin chlorideAccord Healthcare, Inc.ANDACurrent
16729-317oxybutynin chlorideoxybutynin chlorideAccord Healthcare, Inc.ANDACurrent
16729-318oxybutynin chlorideoxybutynin chlorideAccord Healthcare, Inc.ANDACurrent
16729-318oxybutynin chlorideoxybutynin chlorideAccord Healthcare, Inc.ANDACurrent
16729-318oxybutynin chlorideoxybutynin chlorideAccord Healthcare, Inc.ANDACurrent
16729-319oxybutynin chlorideoxybutynin chlorideAccord Healthcare, Inc.ANDACurrent
16729-319oxybutynin chlorideoxybutynin chlorideAccord Healthcare, Inc.ANDACurrent
16729-319oxybutynin chlorideoxybutynin chlorideAccord Healthcare, Inc.ANDACurrent
50090-4307oxybutynin chlorideoxybutynin chlorideA-S Medication SolutionsANDACurrent
50090-4307oxybutynin chlorideoxybutynin chlorideA-S Medication SolutionsANDACurrent
50090-4307oxybutynin chlorideoxybutynin chlorideA-S Medication SolutionsANDACurrent
50090-5822oxybutynin chlorideoxybutynin chlorideA-S Medication SolutionsANDACurrent
55700-647oxybutynin chlorideoxybutynin chlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-647oxybutynin chlorideoxybutynin chlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
68788-7109oxybutynin chlorideoxybutynin chloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7109oxybutynin chlorideoxybutynin chloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7109oxybutynin chlorideoxybutynin chloridePreferred Pharmaceuticals Inc.ANDACurrent
70518-0158oxybutynin chlorideoxybutynin chlorideREMEDYREPACK INC.ANDACurrent
70518-2388oxybutynin chlorideoxybutynin chlorideREMEDYREPACK INC.ANDACurrent
70518-2388oxybutynin chlorideoxybutynin chlorideREMEDYREPACK INC.ANDACurrent
70518-2388oxybutynin chlorideoxybutynin chlorideREMEDYREPACK INC.ANDACurrent
70518-2388oxybutynin chlorideoxybutynin chlorideREMEDYREPACK INC.ANDACurrent
70518-2710oxybutynin chlorideoxybutynin chlorideREMEDYREPACK INC.ANDACurrent
70518-2710oxybutynin chlorideoxybutynin chlorideREMEDYREPACK INC.ANDACurrent
70518-2710oxybutynin chlorideoxybutynin chlorideREMEDYREPACK INC.ANDACurrent
70518-3032oxybutynin chlorideoxybutynin chlorideREMEDYREPACK INC.ANDACurrent
71205-667oxybutynin chlorideoxybutynin chlorideProficient Rx LPANDACurrent
71335-0610oxybutynin chlorideoxybutynin chlorideBryant Ranch PrepackANDACurrent
71335-0610oxybutynin chlorideoxybutynin chlorideBryant Ranch PrepackANDACurrent
71335-0610oxybutynin chlorideoxybutynin chlorideBryant Ranch PrepackANDACurrent
72189-131OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDEdirect rxANDACurrent
72189-132OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDEDIRECT RXANDACurrent
72789-049oxybutynin chlorideoxybutynin chloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-049oxybutynin chlorideoxybutynin chloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-049oxybutynin chlorideoxybutynin chloridePD-Rx Pharmaceuticals, Inc.ANDACurrent