FDA.reportPublic FDA data

Application 076974

Type
ANDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDEINJECTABLE;INJECTIONEQ 2MG BASE/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51662-1377ONDANSETRONONDANSETRONHF Acquisition Co LLC, DBA HealthFirstANDACurrent
63323-374OndansetronONDANSETRON HYDROCHLORIDEFresenius Kabi USA, LLCANDACurrent
63323-374OndansetronONDANSETRON HYDROCHLORIDEFresenius Kabi USA, LLCANDACurrent
63323-374OndansetronONDANSETRON HYDROCHLORIDEFresenius Kabi USA, LLCANDACurrent
63323-374OndansetronONDANSETRON HYDROCHLORIDEFresenius Kabi USA, LLCANDACurrent
65293-374OndansetronONDANSETRON HYDROCHLORIDEThe Medicines CompanyANDACurrent
65293-374OndansetronONDANSETRON HYDROCHLORIDEThe Medicines CompanyANDACurrent