FDA.reportPublic FDA data

Application 078287

Type
ANDA
Sponsor
BAXTER HLTHCARE CORP

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
36000-012ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDEBaxter Healthcare CorporationANDACurrent
36000-012ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDEBaxter Healthcare CorporationANDACurrent
36000-012ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDEBaxter Healthcare CorporationANDACurrent
36000-012ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDEBaxter Healthcare CorporaANDACurrent
36000-012ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDEBaxter Healthcare CorporationANDACurrent
55154-4453ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDECardinal HealthANDACurrent
55154-4453ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDECardinal Health 107, LLCANDACurrent
55154-4453ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDECardinal HealthANDACurrent