BLA 761025

BOEHRINGER INGELHEIM

FDA Drug Application

Application #761025

Documents

• Letter: 2015-10-20
• Label: 2015-10-16
• Review: 2015-11-13
• Label: 2018-04-12
• Letter: 2018-04-16
• Label: 2022-02-14
• Letter: 2022-02-15

Application Sponsors

BLA 761025

BOEHRINGER INGELHEIM

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

2.5G/50ML

0

PRAXBIND

IDARUCIZUMAB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2015-10-16	PRIORITY
EFFICACY; Efficacy	SUPPL	2	AP	2018-04-12	STANDARD
LABELING; Labeling	SUPPL	13	AP	2022-02-11	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	6
SUPPL	13	Null	15

CDER Filings

BOEHRINGER INGELHEIM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761025
            [companyName] => BOEHRINGER INGELHEIM
            [docInserts] => ["",""]
            [products] => [{"drugName":"PRAXBIND","activeIngredients":"IDARUCIZUMAB","strength":"2.5G\/50ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/12\/2018","submission":"SUPPL-2","supplementCategories":"Efficacy-Accelerated Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761025s002lbl.pdf\"}]","notes":""},{"actionDate":"10\/16\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/761025lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/16\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/761025lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/761025Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/0761025Orig1000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"04\/12\/2018","submission":"SUPPL-2","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761025s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761025Orig1s002ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2018-04-12
        )

)