NDA 200795

HOSPIRA INC

FDA Drug Application

Application #200795

Documents

• Label: 2014-05-12
• Summary Review: 2012-07-06
• Letter: 2011-08-08
• Letter: 2013-09-10
• Letter: 2014-05-12
• Label: 2011-08-05
• Label: 2013-09-09
• Review: 2012-07-06
• Letter: 2018-01-30
• Label: 2018-02-14
• Letter: 2019-06-24
• Label: 2019-06-27

Application Sponsors

NDA 200795

HOSPIRA INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	INJECTABLE;INJECTION	200MG/5.26ML (38MG/ML)	1	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE
002	INJECTABLE;INJECTION	1GM/26.3ML (38MG/ML)	1	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE
003	INJECTABLE;INJECTION	2GM/52.6ML (38MG/ML)	1	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2011-08-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2013-06-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2013-11-27	STANDARD
LABELING; Labeling	SUPPL	4	AP	2013-09-05	STANDARD
LABELING; Labeling	SUPPL	5	AP	2014-05-08	901 REQUIRED
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2016-04-07	STANDARD
LABELING; Labeling	SUPPL	8	AP	2018-01-26	STANDARD
LABELING; Labeling	SUPPL	10	AP	2019-06-21	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	15
SUPPL	5	Null	6
SUPPL	6	Null	0
SUPPL	8	Null	7
SUPPL	10	Null	6

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

HOSPIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200795
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GEMCITABINE HYDROCHLORIDE","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"200MG\/5.26ML (38MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"GEMCITABINE HYDROCHLORIDE","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"1GM\/26.3ML (38MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"GEMCITABINE HYDROCHLORIDE","activeIngredients":"GEMCITABINE HYDROCHLORIDE","strength":"2GM\/52.6ML (38MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/21\/2019","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/200795s010lbl.pdf\"}]","notes":""},{"actionDate":"01\/26\/2018","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/200795s008lbl.pdf\"}]","notes":""},{"actionDate":"05\/08\/2014","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/200795s005lbl.pdf\"}]","notes":""},{"actionDate":"09\/05\/2013","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/200795s004lbl.pdf\"}]","notes":""},{"actionDate":"08\/04\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/200795s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/04\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/200795s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/200795s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/200795_gemcitabine_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/200795Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"06\/21\/2019","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/200795s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/200795Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"01\/26\/2018","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/200795s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/200795Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"04\/07\/2016","submission":"SUPPL-6","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/08\/2014","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/200795s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/200795Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"09\/05\/2013","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/200795s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/200795Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"11\/27\/2013","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/20\/2013","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/18\/2012","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-06-21
        )

)