FDA.reportPublic FDA data

Application 077009

Type
ANDA
Sponsor
TARO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDESOLUTION;ORALEQ 4MG BASE/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50436-4091Ondansetronondansetron hydrochlorideUnit Dose ServicesANDACurrent
51672-4091Ondansetronondansetron hydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4091Ondansetronondansetron hydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
68071-1649Ondansetronondansetron hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1649Ondansetronondansetron hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent