Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 761036
Company: JANSSEN BIOTECH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DARZALEX DARATUMUMAB 100MG/5ML INJECTABLE;INJECTION Prescription None TBD No
DARZALEX DARATUMUMAB 400MG/20ML INJECTABLE;INJECTION Prescription None TBD No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/16/2015 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/761036Orig1s000lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/761036Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/761036Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/761036Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/27/2019 SUPPL-20 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761036s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761036Orig1s020ltr.pdf
07/16/2019 SUPPL-19 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761036Orig1s019lbl_.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761036Orig1s019ltr.pdf
02/08/2019 SUPPL-16 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761036s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761036Orig1s016ltr.pdf
06/18/2018 SUPPL-14 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761036s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761036Orig1s014ltr.pdf
05/07/2018 SUPPL-13 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761036s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761036Orig1s013ltr.pdf
06/16/2017 SUPPL-5 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761036s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761036Orig1s005ltr.pdf
11/21/2016 SUPPL-4 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761036s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761036Orig1s004ltr.pdf
11/21/2016 SUPPL-3 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761036s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761036Orig1s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/16/2019 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761036Orig1s019lbl_.pdf
06/27/2019 SUPPL-20 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761036s020lbl.pdf
02/08/2019 SUPPL-16 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761036s016lbl.pdf
06/18/2018 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761036s014lbl.pdf
05/07/2018 SUPPL-13 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761036s013lbl.pdf
06/16/2017 SUPPL-5 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761036s005lbl.pdf
11/21/2016 SUPPL-4 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761036s004lbl.pdf
11/21/2016 SUPPL-3 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761036s003lbl.pdf
11/16/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/761036Orig1s000lbledt.pdf

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