Application 077365

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDEINJECTABLE;INJECTIONEQ 2MG BASE/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0641-6079OndansetronOndansetronHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6079OndansetronOndansetronWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6079OndansetronOndansetronHikma Pharmaceuticals USA Inc.ANDACurrent