HOSPIRA INC FDA Approval NDA 022234

NDA 022234

HOSPIRA INC

FDA Drug Application

Application #022234

Documents

Letter2008-08-13
Letter2011-03-11
Label2011-03-11
Label2014-07-11
Letter2014-07-11
Review2011-12-08
Summary Review2011-12-08
Label2017-09-06
Label2017-09-28
Letter2017-09-29
Letter2018-08-03
Label2018-08-03
Label2018-09-26
Letter2018-10-01
Letter2019-10-15
Letter2019-10-15
Letter2019-10-15
Label2019-10-15
Label2019-10-15
Label2019-10-15
Label2020-11-25
Letter2020-11-27

Application Sponsors

NDA 022234HOSPIRA INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Discontinued006
Prescription007

Application Products

001INJECTABLE;INJECTION20MG/2ML (10MG/ML)1DOCETAXELDOCETAXEL
002INJECTABLE;INJECTION80MG/8ML (10MG/ML)1DOCETAXELDOCETAXEL
003INJECTABLE;INJECTION160MG/16ML (10MG/ML)1DOCETAXELDOCETAXEL
004INJECTABLE;INJECTION20MG/ML (20MG/ML)1DOCETAXELDOCETAXEL
005INJECTABLE;INJECTION80MG/4ML (20MG/ML)1DOCETAXELDOCETAXEL
006INJECTABLE;INJECTION120MG/6ML (20MG/ML)1DOCETAXELDOCETAXEL
007INJECTABLE;INJECTION160MG/8ML (20MG/ML)1DOCETAXELDOCETAXEL

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2011-03-08STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2014-01-23STANDARD
EFFICACY; EfficacySUPPL3AP2014-07-10STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2016-06-24STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2017-01-25STANDARD
LABELING; LabelingSUPPL8AP2017-09-27STANDARD
LABELING; LabelingSUPPL10AP2018-08-02STANDARD
LABELING; LabelingSUPPL11AP2018-09-24STANDARD
LABELING; LabelingSUPPL12AP2019-10-11STANDARD
LABELING; LabelingSUPPL13AP2019-10-11STANDARD
LABELING; LabelingSUPPL15AP2019-10-11STANDARD
LABELING; LabelingSUPPL18AP2020-11-24STANDARD

Submissions Property Types

ORIG1Null31
SUPPL2Null0
SUPPL3Null6
SUPPL4Null0
SUPPL8Null15
SUPPL11Null7
SUPPL12Null15
SUPPL13Null6
SUPPL15Null6
SUPPL18Null7

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP

CDER Filings

HOSPIRA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22234
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"20MG\/2ML (10MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"80MG\/8ML (10MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"160MG\/16ML (10MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"20MG\/ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"80MG\/4ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"120MG\/6ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"160MG\/8ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"10\/11\/2019","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022234s012s013s015lbl.pdf\"}]","notes":""},{"actionDate":"10\/11\/2019","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022234s012s013s015lbl.pdf\"}]","notes":""},{"actionDate":"10\/11\/2019","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022234s012s013s015lbl.pdf\"}]","notes":""},{"actionDate":"10\/11\/2019","submission":"SUPPL-12","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022234s012s013s015lbl.pdf\"}]","notes":""},{"actionDate":"09\/24\/2018","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022234s011,202356s003lbl.pdf\"}]","notes":""},{"actionDate":"08\/02\/2018","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022234Orig1s010Lbl.pdf\"}]","notes":""},{"actionDate":"09\/27\/2017","submission":"SUPPL-8","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022234s008lbl.pdf\"}]","notes":""},{"actionDate":"09\/27\/2017","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022234s008lbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2017","submission":"SUPPL-5","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022234s005lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"07\/10\/2014","submission":"SUPPL-3","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022234s03lbl.pdf\"}]","notes":""},{"actionDate":"03\/08\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022234s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DOCETAXEL","submission":"DOCETAXEL","actionType":"20MG\/2ML (10MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DOCETAXEL","submission":"DOCETAXEL","actionType":"80MG\/8ML (10MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DOCETAXEL","submission":"DOCETAXEL","actionType":"160MG\/16ML (10MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DOCETAXEL","submission":"DOCETAXEL","actionType":"20MG\/ML (20MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DOCETAXEL","submission":"DOCETAXEL","actionType":"80MG\/4ML (20MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DOCETAXEL","submission":"DOCETAXEL","actionType":"120MG\/6ML (20MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"DOCETAXEL","submission":"DOCETAXEL","actionType":"160MG\/8ML (20MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-10-11
        )

)
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