FDA.reportPublic FDA data

Application 210125

Type
ANDA
Sponsor
TULEX PHARMS INC

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
52817-260Oxybutynin Chlorideoxybutynin chlorideTruPharma LLCANDACurrent
52817-260Oxybutynin Chlorideoxybutynin chlorideTruPharma LLCANDACurrent
52817-260Oxybutynin Chlorideoxybutynin chlorideTruPharma LLCANDACurrent
52817-260Oxybutynin Chlorideoxybutynin chlorideTruPharma LLCANDACurrent
52817-260Oxybutynin Chlorideoxybutynin chlorideTruPharma LLCANDACurrent
70404-006Oxybutynin Chlorideoxybutynin chlorideTulex Pharmaceuticals, Inc.ANDACurrent
70404-006Oxybutynin Chlorideoxybutynin chlorideTulex Pharmaceuticals, Inc.ANDACurrent
71610-394Oxybutynin Chlorideoxybutynin chlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-394Oxybutynin Chlorideoxybutynin chlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent