FDA.reportPublic FDA data

Application 090424

Type
ANDA
Sponsor
EMCURE PHARMS

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
23155-168Ondansetron HydrochlorideOndansetron HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-377Ondansetron HydrochlorideOndansetron HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent