FDA.reportPublic FDA data

Application 022234

Type
NDA
Sponsor
HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOCETAXELDOCETAXELINJECTABLE;INJECTION20MG/2ML (10MG/ML)YesYes
002DOCETAXELDOCETAXELINJECTABLE;INJECTION80MG/8ML (10MG/ML)YesYes
003DOCETAXELDOCETAXELINJECTABLE;INJECTION160MG/16ML (10MG/ML)YesYes
004DOCETAXELDOCETAXELINJECTABLE;INJECTION20MG/ML (20MG/ML)YesNo
005DOCETAXELDOCETAXELINJECTABLE;INJECTION80MG/4ML (20MG/ML)YesNo
006DOCETAXELDOCETAXELINJECTABLE;INJECTION120MG/6ML (20MG/ML)YesNo
007DOCETAXELDOCETAXELINJECTABLE;INJECTION160MG/8ML (20MG/ML)YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-0016DocetaxelDOCETAXEL ANHYDROUSHospira, Inc.NDACurrent
0409-0201DocetaxelDOCETAXEL ANHYDROUSHospira, Inc.NDACurrent
0409-0201DocetaxelDOCETAXEL ANHYDROUSHospira, Inc.NDACurrent
0409-0201DocetaxelDOCETAXEL ANHYDROUSHospira, Inc.NDACurrent
0409-0201DocetaxelDOCETAXEL ANHYDROUSHospira, Inc.NDACurrent
0409-0201DocetaxelDOCETAXEL ANHYDROUSHospira, Inc.NDACurrent
0409-0201DocetaxelDOCETAXEL ANHYDROUSHospira, Inc.NDACurrent
0409-0201DocetaxelDOCETAXEL ANHYDROUSHospira, Inc.NDACurrent
0409-0201DocetaxelDOCETAXEL ANHYDROUSHospira, Inc.NDACurrent
0409-0365DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0365DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0366DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0366DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0366DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0366DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0366DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0366DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0366DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0366DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0367DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0367DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0367DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0367DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0367DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0367DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0367DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0367DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0368DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0368DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0368DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0368DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0368DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0368DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0368DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-0368DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-1732DocetaxelDOCETAXEL ANHYDROUSHospira, Inc.NDACurrent
0409-2026DocetaxelDOCETAXEL ANHYDROUSHospira, Inc.NDACurrent
0409-4235DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-4235DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-5068DocetaxelDOCETAXELHospira, Inc.NDACurrent
0409-7870DocetaxelDOCETAXEL ANHYDROUSHospira, Inc.NDACurrent
0409-7870DocetaxelDOCETAXEL ANHYDROUSHospira, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74268SUPPL 2023-05-16
74260SUPPL 2023-05-16
65355SUPPL2020-11-27
65331SUPPL2020-11-25
60561SUPPL2019-10-15
60560SUPPL2019-10-15
60559SUPPL2019-10-15
60557SUPPL2019-10-15
60556SUPPL2019-10-15
60555SUPPL2019-10-15
55748SUPPL2018-10-01
55620SUPPL2018-09-26
55106SUPPL2018-08-03
55095SUPPL2018-08-03
49889SUPPL2017-09-29
49874SUPPL2017-09-28
49666SUPPL2017-09-06
29432SUPPL2014-07-11
17108SUPPL2014-07-11
44709ORIG2011-12-08
42459ORIG2011-12-08
17107ORIG2011-03-11
7075ORIG2011-03-11
7074ORIG2008-08-13