BLA 125433

JANSSEN BIOTECH

FDA Drug Application

Application #125433

Documents

• Letter: 2013-07-26
• Letter: 2014-02-11
• Letter: 2014-12-24
• Letter: 2015-08-10
• Letter: 2016-04-27
• Label: 2013-07-22
• Label: 2014-02-12
• Letter: 2014-02-13
• Letter: 2016-01-11
• Letter: 2016-02-24
• Label: 2014-02-06
• Label: 2015-08-06
• Label: 2016-01-12
• Label: 2016-05-03
• Label: 2016-02-23
• Review: 2013-09-30
• Label: 2016-08-19
• Letter: 2016-08-19
• Letter: 2017-01-31
• Label: 2017-01-30
• Letter: 2017-10-23
• Letter: 2017-10-23
• Label: 2017-10-24
• Label: 2017-10-24
• Label: 2018-02-09
• Medication Guide: 2018-02-09
• Letter: 2018-02-09
• Review: 2018-04-18
• Label: 2019-09-24
• Medication Guide: 2019-09-25
• Letter: 2019-09-25
• Letter: 2020-09-30
• Letter: 2020-09-30
• Label: 2020-10-01
• Medication Guide: 2020-10-01
• Letter: 2021-02-03
• Label: 2021-02-05
• Medication Guide: 2021-02-05

Application Sponsors

BLA 125433

JANSSEN BIOTECH

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE; INJECTION

50MG/4ML

0

SIMPONI ARIA

GOLIMUMAB

FDA Submissions

UNKNOWN;	ORIG	1	AP	2013-07-18	STANDARD
LABELING; Labeling	SUPPL	2	AP	2014-02-04	STANDARD
LABELING; Labeling	SUPPL	5	AP	2014-02-12	STANDARD
LABELING; Labeling	SUPPL	13	AP	2014-12-19	STANDARD
EFFICACY; Efficacy	SUPPL	14	AP	2015-08-05	STANDARD
LABELING; Labeling	SUPPL	15	AP	2016-01-08	STANDARD
LABELING; Labeling	SUPPL	16	AP	2016-04-26	STANDARD
LABELING; Labeling	SUPPL	17	AP	2016-02-22	STANDARD
LABELING; Labeling	SUPPL	18	AP	2016-08-19	STANDARD
LABELING; Labeling	SUPPL	19	AP	2017-01-30	STANDARD
EFFICACY; Efficacy	SUPPL	20	AP	2017-10-20	STANDARD
EFFICACY; Efficacy	SUPPL	21	AP	2017-10-20	STANDARD
LABELING; Labeling	SUPPL	24	AP	2018-02-09	STANDARD
LABELING; Labeling	SUPPL	28	AP	2019-09-24	STANDARD
EFFICACY; Efficacy	SUPPL	30	AP	2020-09-29	STANDARD
EFFICACY; Efficacy	SUPPL	31	AP	2020-09-29	STANDARD
EFFICACY; Efficacy	SUPPL	32	AP	2021-02-01	STANDARD

Submissions Property Types

SUPPL	13	Null	15
SUPPL	14	Null	6
SUPPL	15	Null	7
SUPPL	16	Null	7
SUPPL	17	Null	15
SUPPL	18	Null	6
SUPPL	19	Null	6
SUPPL	20	Null	6
SUPPL	21	Null	7
SUPPL	24	Null	15
SUPPL	28	Null	6
SUPPL	30	Null	15
SUPPL	31	Null	6
SUPPL	32	Null	6

CDER Filings

JANSSEN BIOTECH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 125433
            [companyName] => JANSSEN BIOTECH
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/125433s028lbl.pdf#page=31"]
            [products] => [{"drugName":"SIMPONI ARIA","activeIngredients":"GOLIMUMAB","strength":"50MG\/4ML","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/24\/2019","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125433s028lbl.pdf\"}]","notes":""},{"actionDate":"02\/09\/2018","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125433s024lbl.pdf\"}]","notes":""},{"actionDate":"10\/20\/2017","submission":"SUPPL-21","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125433s020s021lbl.pdf\"}]","notes":""},{"actionDate":"10\/20\/2017","submission":"SUPPL-20","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125433s020s021lbl.pdf\"}]","notes":""},{"actionDate":"01\/30\/2017","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125433s019lbl.pdf\"}]","notes":""},{"actionDate":"08\/19\/2016","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125433s018lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2016","submission":"SUPPL-16","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125433Orig1s016lbl.pdf\"}]","notes":""},{"actionDate":"02\/22\/2016","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125433Orig1s017lbl.pdf\"}]","notes":""},{"actionDate":"02\/22\/2016","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125433Orig1s017lbl.pdf\"}]","notes":""},{"actionDate":"01\/08\/2016","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125433s015lbl.pdf\"}]","notes":""},{"actionDate":"08\/05\/2015","submission":"SUPPL-14","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125433s014lbl.pdf\"}]","notes":""},{"actionDate":"02\/12\/2014","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125433s005lbl.pdf\"}]","notes":""},{"actionDate":"02\/04\/2014","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125433s002lbl.pdf\"}]","notes":""},{"actionDate":"07\/18\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125433s000lbledt.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/18\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125433s000lbledt.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/125433Orig1s000ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/125433review.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"09\/24\/2019","submission":"SUPPL-28","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125433s028lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125433Orig1s028ltr.pdf\"}]","notes":">"},{"actionDate":"02\/09\/2018","submission":"SUPPL-24","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125433s024lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125433Orig1s024ltr.pdf\"}]","notes":">"},{"actionDate":"10\/20\/2017","submission":"SUPPL-21","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label 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site."},{"actionDate":"02\/12\/2014","submission":"SUPPL-5","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125433s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125433Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"02\/04\/2014","submission":"SUPPL-2","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125433s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125433Orig1s002ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-09-24
        )

)