Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761210
Company: JANSSEN BIOTECH
Company: JANSSEN BIOTECH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RYBREVANT | AMIVANTAMAB-VMJW | 350MG/7ML(50MG/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 |
---|---|---|---|---|---|---|---|
05/21/2021 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761210s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761210Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761210Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/01/2024 | SUPPL-3 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761210s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761210Orig1s003ltr.pdf | |
11/04/2022 | SUPPL-2 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761210s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761210Orig1s002ltr.pdf | |
12/21/2021 | SUPPL-1 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761210s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761210Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/01/2024 | SUPPL-3 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761210s003lbl.pdf | |
11/04/2022 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761210s002lbl.pdf | |
12/21/2021 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761210s001lbl.pdf | |
05/21/2021 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761210s000lbl.pdf |