Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761145
Company: JANSSEN BIOTECH
Company: JANSSEN BIOTECH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DARZALEX FASPRO | DARATUMUMAB AND HYALURONIDASE-FIHJ | 120MG;2000UNITS/ML | INJECTABLE;INJECTION | Prescription | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 05/01/2020 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761145s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761145Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761145Orig1s000TOC.html |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/12/2026 | SUPPL-39 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761145s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761145Orig1s039ltr.pdf | |
| 11/14/2025 | SUPPL-35 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761145s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761145Orig1s035ltr.pdf | |
| 11/19/2025 | SUPPL-32 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761145s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761145Orig1s032ltr.pdf | |
| 11/06/2025 | SUPPL-29 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761145s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761145Orig1s029ltr.pdf | |
| 01/27/2026 | SUPPL-28 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761145s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761145Orig1s028ltr.pdf | |
| 07/30/2024 | SUPPL-25 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761145s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761145Orig1s025ltr.pdf | |
| 11/02/2022 | SUPPL-18 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761145s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761145Orig1s018ltr.pdf | |
| 01/21/2022 | SUPPL-12 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761145s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761145Orig1s012ltr.pdf | |
| 11/30/2021 | SUPPL-9 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761145s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761145Orig1s009ltr.pdf | |
| 02/08/2021 | SUPPL-8 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761145s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761145Orig1s008ltr.pdf | |
| 07/09/2021 | SUPPL-7 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761145s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761145Orig1s007ltr.pdf | |
| 03/12/2021 | SUPPL-5 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761145s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761145Orig1s005ltr.pdf | |
| 01/15/2021 | SUPPL-2 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761145s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761145Orig1s002ltr.pdf | |
| 01/11/2021 | SUPPL-1 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761145s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761145Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/12/2026 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761145s039lbl.pdf | |
| 01/27/2026 | SUPPL-28 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761145s028lbl.pdf | |
| 11/19/2025 | SUPPL-32 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761145s032lbl.pdf | |
| 11/14/2025 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761145s035lbl.pdf | |
| 11/06/2025 | SUPPL-29 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761145s029lbl.pdf | |
| 07/30/2024 | SUPPL-25 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761145s025lbl.pdf | |
| 11/02/2022 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761145s018lbl.pdf | |
| 01/21/2022 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761145s012lbl.pdf | |
| 11/30/2021 | SUPPL-9 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761145s009lbl.pdf | |
| 07/09/2021 | SUPPL-7 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761145s007lbl.pdf | |
| 03/12/2021 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761145s005lbl.pdf | |
| 02/08/2021 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761145s008lbl.pdf | |
| 01/15/2021 | SUPPL-2 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761145s002lbl.pdf | |
| 01/11/2021 | SUPPL-1 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761145s001lbl.pdf | |
| 05/01/2020 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761145s000lbl.pdf |