FDA.reportPublic FDA data

Application 211682

Type
ANDA
Sponsor
EMCURE PHARMS LTD

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
14539-653Oxybutynin ChlorideOxybutynin ChlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
14539-653Oxybutynin ChlorideOxybutynin ChlorideHeritage Pharma Labs, IncANDACurrent
70518-2904Oxybutynin ChlorideOxybutynin ChlorideREMEDYREPACK INC.ANDACurrent
70518-2904Oxybutynin ChlorideOxybutynin ChlorideREMEDYREPACK INC.ANDACurrent