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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761228
Company: IMMUNOCORE LTD

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KIMMTRAK TEBENTAFUSP-TEBN 100MCG/0.5ML 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
01/25/2022 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761228s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761228Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761228Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/27/2024 SUPPL-3 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761228s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761228Orig1s003ltr.pdf
11/29/2022 SUPPL-2 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761228s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761228Orig1s002ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
06/27/2024 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761228s003lbl.pdf
11/29/2022 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761228s002lbl.pdf
01/25/2022 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761228s000lbl.pdf
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