Documents
Application Sponsors
| BLA 761036 | JANSSEN BIOTECH | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 100MG/5ML | 2 | DARZALEX | DARATUMUMAB |
| 002 | INJECTABLE;INJECTION | 400MG/20ML | 2 | DARZALEX | DARATUMUMAB |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2015-11-16 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 2016-11-21 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2016-11-21 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2017-06-16 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 13 | AP | 2018-05-07 | PRIORITY |
| LABELING; Labeling | SUPPL | 14 | AP | 2018-06-18 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 16 | AP | 2019-02-08 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2019-07-16 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 20 | AP | 2019-06-27 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 24 | AP | 2019-09-26 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 26 | AP | 2020-06-29 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2020-04-17 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 29 | AP | 2020-08-20 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 2021-03-12 | STANDARD |
| LABELING; Labeling | SUPPL | 35 | AP | 2021-07-09 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 2022-01-21 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 41 | AP | 2022-03-04 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 44 | AP | 2023-01-19 | STANDARD |
| LABELING; Labeling | SUPPL | 45 | AP | 2022-11-01 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 2 |
| SUPPL | 3 | Null | 6 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 14 | Orphan | 5 |
| SUPPL | 16 | Null | 7 |
| SUPPL | 19 | Null | 6 |
| SUPPL | 20 | Null | 7 |
| SUPPL | 24 | Null | 7 |
| SUPPL | 26 | Null | 15 |
| SUPPL | 27 | Null | 6 |
| SUPPL | 29 | Null | 7 |
| SUPPL | 33 | Null | 6 |
| SUPPL | 35 | Null | 7 |
| SUPPL | 40 | Null | 6 |
| SUPPL | 41 | Null | 7 |
| SUPPL | 44 | Null | 6 |
| SUPPL | 45 | Null | 7 |
CDER Filings
JANSSEN BIOTECH
cder:Array
(
[0] => Array
(
[ApplNo] => 761036
[companyName] => JANSSEN BIOTECH
[docInserts] => ["",""]
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[labels] => [{"actionDate":"06\/29\/2020","submission":"SUPPL-26","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761036s026lbl.pdf\"}]","notes":""},{"actionDate":"04\/17\/2020","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761036s027lbl.pdf\"}]","notes":""},{"actionDate":"09\/26\/2019","submission":"SUPPL-24","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761036s024lbl.pdf\"}]","notes":""},{"actionDate":"07\/16\/2019","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761036Orig1s019lbl_.pdf\"}]","notes":""},{"actionDate":"06\/27\/2019","submission":"SUPPL-20","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761036s020lbl.pdf\"}]","notes":""},{"actionDate":"02\/08\/2019","submission":"SUPPL-16","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761036s016lbl.pdf\"}]","notes":""},{"actionDate":"06\/18\/2018","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761036s014lbl.pdf\"}]","notes":""},{"actionDate":"05\/07\/2018","submission":"SUPPL-13","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761036s013lbl.pdf\"}]","notes":""},{"actionDate":"06\/16\/2017","submission":"SUPPL-5","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761036s005lbl.pdf\"}]","notes":""},{"actionDate":"11\/21\/2016","submission":"SUPPL-4","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/761036s004lbl.pdf\"}]","notes":""},{"actionDate":"11\/21\/2016","submission":"SUPPL-3","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/761036s003lbl.pdf\"}]","notes":""},{"actionDate":"11\/16\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/761036Orig1s000lbledt.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"11\/16\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/761036Orig1s000lbledt.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/761036Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/761036Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/761036Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"04\/17\/2020","submission":"SUPPL-27","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761036s027lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761036Orig1s027ltr.pdf\"}]","notes":">"},{"actionDate":"06\/29\/2020","submission":"SUPPL-26","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761036s026lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761036Orig1s026ltr.pdf\"}]","notes":">"},{"actionDate":"09\/26\/2019","submission":"SUPPL-24","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761036s024lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761036Orig1s024ltr.pdf\"}]","notes":">"},{"actionDate":"06\/27\/2019","submission":"SUPPL-20","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761036s020lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761036Orig1s020ltr.pdf\"}]","notes":">"},{"actionDate":"07\/16\/2019","submission":"SUPPL-19","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761036Orig1s019lbl_.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761036Orig1s019ltr.pdf\"}]","notes":">"},{"actionDate":"02\/08\/2019","submission":"SUPPL-16","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761036s016lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761036Orig1s016ltr.pdf\"}]","notes":">"},{"actionDate":"06\/18\/2018","submission":"SUPPL-14","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761036s014lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761036Orig1s014ltr.pdf\"}]","notes":">"},{"actionDate":"05\/07\/2018","submission":"SUPPL-13","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761036s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761036Orig1s013ltr.pdf\"}]","notes":">"},{"actionDate":"06\/16\/2017","submission":"SUPPL-5","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761036s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/761036Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"11\/21\/2016","submission":"SUPPL-4","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/761036s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/761036Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"11\/21\/2016","submission":"SUPPL-3","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/761036s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/761036Orig1s003ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-06-29
)
)