Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761036
Company: JANSSEN BIOTECH
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 |
|---|---|---|---|---|---|
| 11/01/2022 | SUPPL-45 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761036s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761036Orig1s045ltr.pdf | |
| 01/19/2023 | SUPPL-44 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761036s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761036Orig1s044ltr.pdf | |
| 03/04/2022 | SUPPL-41 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761036s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761036Orig1s041ltr.pdf | |
| 01/21/2022 | SUPPL-40 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761036s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761036Orig1s040ltr.pdf | |
| 07/09/2021 | SUPPL-35 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761036s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761036Orig1s035ltr.pdf | |
| 03/12/2021 | SUPPL-33 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761036s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761036Orig1s033ltr.pdf | |
| 08/20/2020 | SUPPL-29 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761036s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761036Orig1s029ltr.pdf | |
| 04/17/2020 | SUPPL-27 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761036s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761036Orig1s027ltr.pdf | |
| 06/29/2020 | SUPPL-26 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761036s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761036Orig1s026ltr.pdf | |
| 09/26/2019 | SUPPL-24 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761036s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761036Orig1s024ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 01/19/2023 | SUPPL-44 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761036s044lbl.pdf | |
| 11/01/2022 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761036s045lbl.pdf | |
| 03/04/2022 | SUPPL-41 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761036s041lbl.pdf | |
| 01/21/2022 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761036s040lbl.pdf | |
| 07/09/2021 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761036s035lbl.pdf | |
| 03/12/2021 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761036s033lbl.pdf | |
| 08/20/2020 | SUPPL-29 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761036s029lbl.pdf | |
| 06/29/2020 | SUPPL-26 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761036s026lbl.pdf | |
| 04/17/2020 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761036s027lbl.pdf | |
| 09/26/2019 | SUPPL-24 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761036s024lbl.pdf | |
| 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-New Indication | 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 |