FDA.reportPublic FDA data

Application 074868

Type
ANDA
Sponsor
WOCKHARDT BIO AG

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDESYRUP;ORAL5MG/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17856-0092Oxybutynin ChlorideOxybutynin ChlorideAtlantic Biologicals CorpsANDACurrent
17856-0092Oxybutynin ChlorideOxybutynin ChlorideAtlantic Biologicals CorpsANDACurrent
17856-0092Oxybutynin ChlorideOxybutynin ChlorideAtlantic Biologicals CorpsANDACurrent
60432-092OXYBUTYNIN CHLORIDEoxybutynin chlorideMorton Grove Pharmaceuticals, Inc.ANDACurrent
68151-9200Oxybutynin ChlorideOxybutynin ChlorideCarilion Materials ManagementANDACurrent