FDA.reportPublic FDA data

Application 078629

Type
ANDA
Sponsor
HIKMA FARMACEUTICA

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
0143-9744Granisetron HydrochlorideGranisetron HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9744Granisetron HydrochlorideGranisetron HydrochlorideWest-Ward Pharmaceuticals CorpANDACurrent
0143-9745Granisetron HydrochlorideGranisetron HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9745Granisetron HydrochlorideGranisetron HydrochlorideWest-Ward Pharmaceuticals CorpANDACurrent