FDA.reportPublic FDA data

Application 204238

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

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
55150-175Granisetron HydrochlorideGranisetron HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-175Granisetron HydrochlorideGranisetron HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-175Granisetron HydrochlorideGranisetron HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-176Granisetron HydrochlorideGranisetron HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-176Granisetron HydrochlorideGranisetron HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-176Granisetron HydrochlorideGranisetron HydrochlorideAuroMedics Pharma LLCANDACurrent