FDA.reportPublic FDA data

Application 212798

Type
ANDA
Sponsor
LEADING PHARMA LLC

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
50090-6199OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDEA-S Medication SolutionsANDACurrent
69315-182OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDELeading Pharma, LLCANDACurrent
69315-182OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDELeading Pharma, LLCANDACurrent
70518-3473OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDEREMEDYREPACK INC.ANDACurrent