FDA.reportPublic FDA data

Application 077541

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

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
0641-6078OndansetronOndansetronWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6078OndansetronOndansetronHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6078OndansetronOndansetronHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6080OndansetronOndansetronHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6080OndansetronOndansetronWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6080OndansetronOndansetronHikma Pharmaceuticals USA Inc.ANDACurrent
51662-1245ONDANSETRONONDANSETRONHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1245ONDANSETRONONDANSETRONHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1245ONDANSETRONONDANSETRONHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1245ONDANSETRONONDANSETRONHF Acquisition Co LLC, DBA HealthFirstANDACurrent
55154-2876OndansetronOndansetronCardinal HealthANDACurrent
55154-2876OndansetronOndansetronCardinal Health 107, LLCANDACurrent
55154-2876OndansetronOndansetronCardinal HealthANDACurrent
55154-2877OndansetronOndansetronCardinal Health 107, LLCANDACurrent
55154-2877OndansetronOndansetronCardinal HealthANDACurrent
71872-7140OndansetronOndansetronMedical Purchasing Solutions, LLCANDACurrent
71872-7140OndansetronOndansetronMedical Purchasing Solutions, LLCANDACurrent
72572-520OndansetronOndansetronCivica, Inc.ANDACurrent
72572-520OndansetronOndansetronCivica, Inc.ANDACurrent
72572-520OndansetronOndansetronCivica, Inc.ANDACurrent