FDA.reportPublic FDA data

Application 206121

Type
ANDA
Sponsor
UNIQUE PHARM LABS

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
64980-209Oxybutynin ChlorideOxybutynin ChlorideRising Pharmaceuticals, Inc.ANDACurrent
64980-209Oxybutynin ChlorideOxybutynin ChlorideRising Pharmaceuticals, Inc.ANDACurrent
64980-209Oxybutynin ChlorideOxybutynin ChlorideRising Pharmaceuticals, Inc.ANDACurrent
64980-210Oxybutynin ChlorideOxybutynin ChlorideRising Pharmaceuticals, Inc.ANDACurrent
64980-210Oxybutynin ChlorideOxybutynin ChlorideRising Pharmaceuticals, Inc.ANDACurrent
64980-210Oxybutynin ChlorideOxybutynin ChlorideRising Pharmaceuticals, Inc.ANDACurrent
64980-211Oxybutynin ChlorideOxybutynin ChlorideRising Pharmaceuticals, Inc.ANDACurrent
64980-211Oxybutynin ChlorideOxybutynin ChlorideRising Pharmaceuticals, Inc.ANDACurrent
64980-211Oxybutynin ChlorideOxybutynin ChlorideRising Pharmaceuticals, Inc.ANDACurrent
70518-0705Oxybutynin ChlorideOxybutynin ChlorideREMEDYREPACK INC.ANDACurrent
70518-0705Oxybutynin ChlorideOxybutynin ChlorideREMEDYREPACK INC.ANDACurrent
71335-2121Oxybutynin ChlorideOxybutynin ChlorideBryant Ranch PrepackANDACurrent