FDA.reportPublic FDA data

Application 211062

Type
ANDA
Sponsor
ATHEM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDETABLET;ORAL5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68788-7785Oxybutynin ChlorideOxybutynin ChloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7785Oxybutynin ChlorideOxybutynin ChloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7785Oxybutynin ChlorideOxybutynin ChloridePreferred Pharmaceuticals Inc.ANDACurrent
70518-2688Oxybutynin ChlorideOxybutynin ChlorideREMEDYREPACK INC.ANDACurrent
70518-2688Oxybutynin ChlorideOxybutynin ChlorideREMEDYREPACK INC.ANDACurrent
70518-2688Oxybutynin ChlorideOxybutynin ChlorideREMEDYREPACK INC.ANDACurrent
71930-051Oxybutynin ChlorideOxybutynin ChlorideEywa Pharma IncANDACurrent