FDA.reportPublic FDA data

Application 079078

Type
ANDA
Sponsor
AKORN INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GRANISETRON HYDROCHLORIDEGRANISETRON HYDROCHLORIDEINJECTABLE;INJECTIONEQ 1MG BASE/ML (EQ 1MG BASE/ML)NoNo
002GRANISETRON HYDROCHLORIDEGRANISETRON HYDROCHLORIDEINJECTABLE;INJECTIONEQ 4MG BASE/4ML (EQ 1MG BASE/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17478-546Granisetron HydrochlorideGranisetron HydrochlorideAkornANDACurrent
17478-546Granisetron HydrochlorideGranisetron HydrochlorideAkornANDACurrent
17478-546Granisetron HydrochlorideGranisetron HydrochlorideAkorn, Inc.ANDACurrent
17478-546Granisetron HydrochlorideGranisetron HydrochlorideAkornANDACurrent
17478-546Granisetron HydrochlorideGranisetron HydrochlorideAkorn, Inc.ANDACurrent
17478-546Granisetron HydrochlorideGranisetron HydrochlorideAkorn, Inc.ANDACurrent