FDA.reportPublic FDA data

Application 076960

Type
ANDA
Sponsor
HIKMA

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
0054-0064Ondansetron HydrochlorideOndansetron HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0064Ondansetron HydrochlorideOndansetron HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0064Ondansetron HydrochlorideOndansetron HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
68094-763Ondansetron HydrochlorideOndansetron HydrochloridePrecision Dose Inc.ANDACurrent
68094-763Ondansetron HydrochlorideOndansetron HydrochloridePrecision Dose Inc.ANDACurrent
68094-763Ondansetron HydrochlorideOndansetron HydrochloridePrecision Dose Inc.ANDACurrent
68151-1668Ondansetron HydrochlorideOndansetron HydrochlorideCarilion Materials ManagementANDACurrent