NDA 200582

HOSPIRA INC

FDA Drug Application

Application #200582

Documents

• Letter: 2014-03-05
• Label: 2011-02-04
• Label: 2016-02-25
• Summary Review: 2011-05-13
• Letter: 2011-02-07
• Letter: 2016-01-29
• Label: 2014-03-04
• Review: 2011-05-13
• Label: 2019-12-17
• Letter: 2019-12-19

Application Sponsors

NDA 200582

HOSPIRA INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

1

TOPOTECAN HYDROCHLORIDE

TOPOTECAN HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2011-02-02	STANDARD
LABELING; Labeling	SUPPL	2	AP	2016-01-29	STANDARD
LABELING; Labeling	SUPPL	3	AP	2019-12-16	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	7
SUPPL	3	Null	31

TE Codes

001

Prescription

AP

CDER Filings

HOSPIRA INC

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(
    [0] => Array
        (
            [ApplNo] => 200582
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOPOTECAN HYDROCHLORIDE","activeIngredients":"TOPOTECAN HYDROCHLORIDE","strength":"EQ 4MG BASE\/4ML (EQ 1MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/16\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/200582s003lbl.pdf\"}]","notes":""},{"actionDate":"01\/29\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/200582s002lbl.pdf\"}]","notes":""},{"actionDate":"02\/28\/2014","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/200582s001lbl.pdf\"}]","notes":""},{"actionDate":"02\/02\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/200582s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/02\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/200582s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/200582s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/200582_topotecan_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/200582Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"12\/16\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/200582s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/200582Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"01\/29\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/200582s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/200582Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"02\/28\/2014","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/200582s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/200582Origs001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-12-16
        )

)