FDA.reportPublic FDA data

Application 078339

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 200MG BASE/VIALNoNo
002GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 1GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-0185GemcitabineGEMCITABINEHospira, Inc.ANDACurrent
0409-0185GemcitabineGEMCITABINEHospira, Inc.ANDACurrent
0409-0185GemcitabineGEMCITABINEHospira, Inc.ANDACurrent
0409-0185GemcitabineGEMCITABINEHospira, Inc.ANDACurrent
0409-0186GemcitabineGEMCITABINEHospira, Inc.ANDACurrent
0409-0186GemcitabineGEMCITABINEHospira, Inc.ANDACurrent
0409-0186GemcitabineGEMCITABINEHospira, Inc.ANDACurrent
0409-0186GemcitabineGEMCITABINEHospira, Inc.ANDACurrent