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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761270
Company: ASTRAZENECA AB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IMJUDO TREMELIMUMAB-ACTL 25MG/1.25ML(20MG/ML) INJECTABLE;INTRAVENOUS Prescription None No No
IMJUDO TREMELIMUMAB-ACTL 300MG/15ML(20MG/ML) INJECTABLE;INTRAVENOUS 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
11/10/2022 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761270s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761270Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761270Orig1s000TOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/10/2022 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761270s000lbl.pdf
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