BLA 761058

BOEHRINGER INGELHEIM

FDA Drug Application

Application #761058

Documents

• Label: 2017-08-25
• Letter: 2017-08-28
• Review: 2018-09-27
• Label: 2019-09-16
• Medication Guide: 2019-09-16
• Letter: 2019-09-17
• Label: 2021-10-19
• Medication Guide: 2021-10-19
• Letter: 2021-10-20
• Letter: 2022-10-04
• Label: 2022-10-05

Application Sponsors

BLA 761058

BOEHRINGER INGELHEIM

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

40MG/0.8ML

0

CYLTEZO

ADALIMUMAB-ADBM

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	2017-08-25	STANDARD
LABELING; Labeling	SUPPL	3	AP	2019-09-13	STANDARD
EFFICACY; Efficacy	SUPPL	8	AP	2021-10-15	STANDARD
LABELING; Labeling	SUPPL	14	TA	2022-04-04	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7
SUPPL	8	Null	7

CDER Filings

BOEHRINGER INGELHEIM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761058
            [companyName] => BOEHRINGER INGELHEIM
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/761058s003lbl.pdf#page=30"]
            [products] => [{"drugName":"CYLTEZO","activeIngredients":"ADALIMUMAB-ADBM","strength":"40MG\/0.8ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/13\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761058s003lbl.pdf\"}]","notes":""},{"actionDate":"08\/25\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761058lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/25\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761058lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/761058Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/761058Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"09\/13\/2019","submission":"SUPPL-3","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761058s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761058Orig1s003ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-09-13
        )

)