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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761210
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
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
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
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