FDA.reportPublic FDA data

Application 091136

Type
ANDA
Sponsor
MYLAN ASI

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GRANISETRON HYDROCHLORIDEGRANISETRON HYDROCHLORIDEINJECTABLE;INJECTIONEQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)NoNo
002GRANISETRON HYDROCHLORIDEGRANISETRON HYDROCHLORIDEINJECTABLE;INJECTIONEQ 1MG BASE/ML (EQ 1MG BASE/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
25021-779granisetron hydrochloridegranisetron hydrochlorideSagent PharmaceuticalsANDACurrent
67457-861Granisetron HydrochlorideGranisetron HydrochlorideMylan Institutional LLCANDACurrent
67457-861Granisetron HydrochlorideGranisetron HydrochlorideMylan Institutional LLCANDACurrent
67457-863Granisetron HydrochlorideGranisetron HydrochlorideMylan Institutional LLCANDACurrent
67457-863Granisetron HydrochlorideGranisetron HydrochlorideMylan Institutional LLCANDACurrent