FDA.reportPublic FDA data

Application 079119

Type
ANDA
Sponsor
AKORN INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GRANISETRON HYDROCHLORIDEGRANISETRON HYDROCHLORIDEINJECTABLE;INJECTIONEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17478-547Granisetron HydrochlorideGranisetron HydrochlorideAkornANDACurrent
17478-547Granisetron HydrochlorideGranisetron HydrochlorideAkorn, Inc.ANDACurrent
17478-547Granisetron HydrochlorideGranisetron HydrochlorideAkorn, Inc.ANDACurrent
17478-547Granisetron HydrochlorideGranisetron HydrochlorideAkorn, Inc.ANDACurrent