FDA.reportPublic FDA data

Application 209823

Type
ANDA
Sponsor
NOVITIUM PHARMA

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
0904-7027Oxybutynin ChlorideOxybutynin ChlorideMajor PharmaceuticalsANDACurrent
10135-640Oxybutynin ChlorideOxybutynin ChlorideMarlex Pharmaceuticals IncANDACurrent
10135-640Oxybutynin ChlorideOxybutynin ChlorideMarlex Pharmaceuticals IncANDACurrent
51407-099Oxybutynin ChlorideOxybutynin ChlorideGolden State Medical Supply Inc.ANDACurrent
51407-099Oxybutynin ChlorideOxybutynin ChlorideGolden State Medical Supply Inc.ANDACurrent
51407-099Oxybutynin ChlorideOxybutynin ChlorideGolden State Medical Supply, Inc.ANDACurrent
66267-642Oxybutynin ChlorideOxybutynin ChlorideNuCare Pharmaceuticals,Inc.ANDACurrent
66267-642Oxybutynin ChlorideOxybutynin ChlorideNuCare Pharmaceuticals,Inc.ANDACurrent
70518-1941Oxybutynin ChlorideOxybutynin ChlorideREMEDYREPACK INC.ANDACurrent
70518-1941Oxybutynin ChlorideOxybutynin ChlorideREMEDYREPACK INC.ANDACurrent
70518-1941Oxybutynin ChlorideOxybutynin ChlorideREMEDYREPACK INC.ANDACurrent
70518-1941Oxybutynin ChlorideOxybutynin ChlorideREMEDYREPACK INC.ANDACurrent
70518-1941Oxybutynin ChlorideOxybutynin ChlorideREMEDYREPACK INC.ANDACurrent
70518-1941Oxybutynin ChlorideOxybutynin ChlorideREMEDYREPACK INC.ANDACurrent
70518-1941Oxybutynin ChlorideOxybutynin ChlorideREMEDYREPACK INC.ANDACurrent
70934-529Oxybutynin ChlorideOxybutynin ChlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-909Oxybutynin ChlorideOxybutynin ChlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-909Oxybutynin ChlorideOxybutynin ChlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70954-005Oxybutynin ChlorideOxybutynin ChlorideNovitium Pharma LLCANDACurrent
70954-005Oxybutynin ChlorideOxybutynin ChlorideNovitium Pharma LLCANDACurrent
71335-1160Oxybutynin ChlorideOxybutynin ChlorideBryant Ranch PrepackANDACurrent
71335-1160Oxybutynin ChlorideOxybutynin ChlorideBryant Ranch PrepackANDACurrent
71610-277Oxybutynin ChlorideOxybutynin ChlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent