BLA 761044

JANSSEN BIOTECH

FDA Drug Application

Application #761044

Documents

• Label: 2016-09-29
• Letter: 2016-09-26
• Review: 2018-01-12
• Letter: 2019-10-24
• Label: 2019-10-21
• Medication Guide: 2019-10-21
• Letter: 2019-11-12
• Label: 2019-11-14
• Medication Guide: 2019-11-14
• Label: 2020-04-13
• Medication Guide: 2020-04-13
• Label: 2020-12-01
• Medication Guide: 2020-12-01
• Letter: 2020-12-02
• Label: 2020-12-14
• Medication Guide: 2020-12-14
• Letter: 2020-12-15
• Review: 2021-09-24
• Letter: 2022-08-01
• Label: 2022-08-01
• Medication Guide: 2022-08-01

Application Sponsors

BLA 761044

JANSSEN BIOTECH

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

130MG/26ML

0

STELARA

USTEKINUMAB

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2016-09-23	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2019-10-18	STANDARD
LABELING; Labeling	SUPPL	5	AP	2020-04-07	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-12-01	STANDARD
LABELING; Labeling	SUPPL	8	AP	2020-12-11	STANDARD
LABELING; Labeling	SUPPL	10	AP	2022-07-29	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	3	Null	7
SUPPL	6	Null	7
SUPPL	8	Null	7
SUPPL	10	Null	6

CDER Filings

JANSSEN BIOTECH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761044
            [companyName] => JANSSEN BIOTECH
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/125261Orig1s153,761044s005lbl.pdf#page=39"]
            [products] => [{"drugName":"STELARA","activeIngredients":"USTEKINUMAB","strength":"130MG\/26ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/07\/2020","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125261Orig1s153,761044s005lbl.pdf\"}]","notes":""},{"actionDate":"11\/07\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125261s142,761044s001lbl.pdf\"}]","notes":""},{"actionDate":"10\/18\/2019","submission":"SUPPL-3","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761044s003lbl.pdf\"}]","notes":""},{"actionDate":"09\/23\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/761044lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/23\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/761044lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/761044Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/761044Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"04\/07\/2020","submission":"SUPPL-5","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125261Orig1s153,761044s005lbl.pdf\"}]","notes":">"},{"actionDate":"10\/18\/2019","submission":"SUPPL-3","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761044s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"11\/07\/2019","submission":"SUPPL-1","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125261s142,761044s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"}]
            [actionDate] => 2020-04-07
        )

)