FDA.reportPublic FDA data

Application 077548

Type
ANDA
Sponsor
HOSPIRA

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
0409-4755OndansetronONDANSETRONHospira, Inc.ANDACurrent
0409-4755OndansetronONDANSETRONHospira, Inc.ANDACurrent
0409-4755OndansetronONDANSETRONHospira, Inc.ANDACurrent
0409-4755OndansetronONDANSETRONHospira, Inc.ANDACurrent
0409-4755OndansetronONDANSETRONHospira, Inc.ANDACurrent
0409-4755OndansetronONDANSETRONHospira, Inc.ANDACurrent
0409-4755OndansetronONDANSETRONHospira, Inc.ANDACurrent
51662-1469ONDANSETRONONDANSETRONHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1469ONDANSETRONONDANSETRONHF Acquisition Co LLC, DBA HealthFirstANDACurrent
55154-4731Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDECardinal HealthANDACurrent
55154-6976Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDECardinal Health 107, LLCANDACurrent
55154-6976Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDECardinal HealthANDACurrent
55154-6976Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDECardinal HealthANDACurrent
55154-6976Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDECardinal HealthANDACurrent
55154-6976Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDECardinal HealthANDACurrent
68071-4810OndansetronONDANSETRONNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4810OndansetronONDANSETRONNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4810OndansetronONDANSETRONNuCare Pharmaceuticals,Inc.ANDACurrent
71872-7162OndansetronONDANSETRONMedical Purchasing Solutions, LLCANDACurrent