Documents
Application Sponsors
BLA 125418 | SANOFI AVENTIS US | |
Marketing Status
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":""}]
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[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
)
)