BLA 125418

SANOFI AVENTIS US

FDA Drug Application

Application #125418

Documents

• Letter: 2015-09-18
• Letter: 2016-06-27
• Label: 2012-08-03
• Label: 2016-03-14
• Review: 2012-09-06
• Letter: 2012-08-03
• Letter: 2013-10-28
• Letter: 2016-03-11
• Label: 2013-10-31
• Label: 2016-06-27
• Summary Review: 2012-09-06
• Letter: 2019-11-27
• Label: 2019-11-29
• Letter: 2020-03-12
• Label: 2020-03-12
• Label: 2020-06-08
• Letter: 2020-06-08

Application Sponsors

BLA 125418

SANOFI AVENTIS US

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE; INJECTION

4MG

0

ZALTRAP

ZIV-AFLIBERCEPT

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2012-08-03	PRIORITY
LABELING; Labeling	SUPPL	20	AP	2013-10-25	STANDARD
EFFICACY; Efficacy	SUPPL	33	AP	2015-09-17	STANDARD
LABELING; Labeling	SUPPL	37	AP	2016-03-09	STANDARD
LABELING; Labeling	SUPPL	39	AP	2016-06-24	STANDARD
LABELING; Labeling	SUPPL	45	AP	2019-11-25	STANDARD
LABELING; Labeling	SUPPL	46	AP	2020-03-11	STANDARD
LABELING; Labeling	SUPPL	47	AP	2020-06-05	STANDARD

Submissions Property Types

SUPPL	33	Null	15
SUPPL	37	Null	6
SUPPL	39	Null	6
SUPPL	45	Null	33
SUPPL	46	Null	6
SUPPL	47	Null	6

CDER Filings

SANOFI AVENTIS US

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 125418
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZALTRAP","activeIngredients":"ZIV-AFLIBERCEPT","strength":"4MG","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/05\/2020","submission":"SUPPL-47","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125418s047lbl.pdf\"}]","notes":""},{"actionDate":"03\/11\/2020","submission":"SUPPL-46","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125418s046lbl.pdf\"}]","notes":""},{"actionDate":"11\/25\/2019","submission":"SUPPL-45","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125418s045lbl.pdf\"}]","notes":""},{"actionDate":"06\/24\/2016","submission":"SUPPL-39","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125418s039lbl.pdf\"}]","notes":""},{"actionDate":"03\/09\/2016","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125418s037lbl.pdf\"}]","notes":""},{"actionDate":"10\/25\/2013","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125418s020lbl.pdf\"}]","notes":""},{"actionDate":"08\/03\/2012","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125418s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/03\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125418s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/125418Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/125418_zaltrap_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/125418Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"06\/05\/2020","submission":"SUPPL-47","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125418s047lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125418Orig1s047ltr.pdf\"}]","notes":">"},{"actionDate":"03\/11\/2020","submission":"SUPPL-46","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125418s046lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125418Orig1s046ltr.pdf\"}]","notes":">"},{"actionDate":"11\/25\/2019","submission":"SUPPL-45","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125418s045lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125418Orig1s045ltr.pdf\"}]","notes":">"},{"actionDate":"06\/24\/2016","submission":"SUPPL-39","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125418s039lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125418Orig1s039ltr.pdf\"}]","notes":">"},{"actionDate":"03\/09\/2016","submission":"SUPPL-37","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125418s037lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125418Orig1s037ltr.pdf\"}]","notes":">"},{"actionDate":"09\/17\/2015","submission":"SUPPL-33","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125418Orig1s033ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"10\/25\/2013","submission":"SUPPL-20","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125418s020lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/125418Orig1s020ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-06-05
        )

)