Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761291
Company: JANSSEN BIOTECH
Company: JANSSEN BIOTECH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TECVAYLI | TECLISTAMAB-CQYV | 30MG/3ML(10MG/ML) | INJECTABLE;INJECTION | Prescription | None | No | No |
TECVAYLI | TECLISTAMAB-CQYV | 153MG/1.7ML(90MG/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 |
---|---|---|---|---|---|---|---|
10/25/2022 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761291s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761291Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761291Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/02/2024 | SUPPL-9 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761291Orig1s007,761342Orig1s005ltr.pdf |
05/28/2024 | SUPPL-8 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761291s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761291Orig1s008ltr.pdf | |
07/02/2024 | SUPPL-7 | Supplement |
Label is not available on this site. |
||
11/16/2023 | SUPPL-5 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761291Orig1s005ltr.pdf |
08/09/2023 | SUPPL-4 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761291s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761291Orig1s004ltr.pdf | |
02/20/2024 | SUPPL-3 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761291s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761291Orig1s003ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/28/2024 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761291s008lbl.pdf | |
02/20/2024 | SUPPL-3 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761291s003lbl.pdf | |
08/09/2023 | SUPPL-4 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761291s004lbl.pdf | |
10/25/2022 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761291s000lbl.pdf |