FDA.reportPublic FDA data

Application 207005

Type
ANDA
Sponsor
HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PALONOSETRON HYDROCHLORIDEPALONOSETRON HYDROCHLORIDEINJECTABLE;INTRAVENOUSEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)NoNo
002PALONOSETRON HYDROCHLORIDEPALONOSETRON HYDROCHLORIDEINJECTABLE;INTRAVENOUSEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-2504Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2504Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2504Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-2504Palonosetron HydrochloridePALONOSETRON HYDROCHLORIDEHospira, Inc.ANDACurrent