FDA.reportPublic FDA data

Application 200795

Type
NDA
Sponsor
HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDEINJECTABLE;INJECTION200MG/5.26ML (38MG/ML)YesYes
002GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDEINJECTABLE;INJECTION1GM/26.3ML (38MG/ML)YesYes
003GEMCITABINE HYDROCHLORIDEGEMCITABINE HYDROCHLORIDEINJECTABLE;INJECTION2GM/52.6ML (38MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-0181GemcitabineGEMCITABINEHospira, Inc.NDACurrent
0409-0181GemcitabineGEMCITABINEHospira, Inc.NDACurrent
0409-0181GemcitabineGEMCITABINEHospira, Inc.NDACurrent
0409-0181GemcitabineGEMCITABINEHospira, Inc.NDACurrent
0409-0181GemcitabineGEMCITABINEHospira, Inc.NDACurrent
0409-0181GemcitabineGEMCITABINEHospira, Inc.NDACurrent
0409-0181GemcitabineGEMCITABINEHospira, Inc.NDACurrent
0409-0181GemcitabineGEMCITABINEHospira, Inc.NDACurrent
0409-0182GemcitabineGEMCITABINEHospira, Inc.NDACurrent
0409-0182GemcitabineGEMCITABINEHospira, Inc.NDACurrent
0409-0182GemcitabineGEMCITABINEHospira, Inc.NDACurrent
0409-0182GemcitabineGEMCITABINEHospira, Inc.NDACurrent
0409-0182GemcitabineGEMCITABINEHospira, Inc.NDACurrent
0409-0182GemcitabineGEMCITABINEHospira, Inc.NDACurrent
0409-0182GemcitabineGEMCITABINEHospira, Inc.NDACurrent
0409-0182GemcitabineGEMCITABINEHospira, Inc.NDACurrent
0409-0183GemcitabineGEMCITABINEHospira, Inc.NDACurrent
0409-0183GemcitabineGEMCITABINEHospira, Inc.NDACurrent
0409-0183GemcitabineGEMCITABINEHospira, Inc.NDACurrent
0409-0183GemcitabineGEMCITABINEHospira, Inc.NDACurrent
0409-0183GemcitabineGEMCITABINEHospira, Inc.NDACurrent
0409-0183GemcitabineGEMCITABINEHospira, Inc.NDACurrent
0409-0183GemcitabineGEMCITABINEHospira, Inc.NDACurrent
0409-0183GemcitabineGEMCITABINEHospira, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78619SUPPL 2024-06-04
78612SUPPL 2024-06-03
59178SUPPL2019-06-27
59161SUPPL2019-06-24
52621SUPPL2018-02-14
52134SUPPL2018-01-30
32062SUPPL2014-05-12
18980SUPPL2014-05-12
32061SUPPL2013-09-10
40046SUPPL2013-09-09
43356ORIG2012-07-06
24388ORIG2012-07-06
32060ORIG2011-08-08
40045ORIG2011-08-05