FDA.reportPublic FDA data

Application 076972

Type
ANDA
Sponsor
FRESENIUS KABI USA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51662-1366ONDANSETRONONDANSETRONHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1366ONDANSETRONONDANSETRONHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1366ONDANSETRONONDANSETRONHF Acquisition Co LLC, DBA HealthFirstANDACurrent
63323-373OndansetronONDANSETRON HYDROCHLORIDEFresenius Kabi USA, LLCANDACurrent
63323-373OndansetronONDANSETRON HYDROCHLORIDEFresenius Kabi USA, LLCANDACurrent
63323-373OndansetronONDANSETRON HYDROCHLORIDEFresenius Kabi USA, LLCANDACurrent
63323-373OndansetronONDANSETRON HYDROCHLORIDEFresenius Kabi USA, LLCANDACurrent
65293-373OndansetronONDANSETRON HYDROCHLORIDEThe Medicines CompanyANDACurrent
65293-373OndansetronONDANSETRON HYDROCHLORIDEThe Medicines CompanyANDACurrent