FDA.reportPublic FDA data

Application 078945

Type
ANDA
Sponsor
EMCURE PHARMS LTD

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
23155-196Ondansetron HydrochlorideOndansetron HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-378Ondansetron HydrochlorideOndansetron HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent