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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761315
Company: NOVO NORDISK INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALHEMO CONCIZUMAB-MTCI 60MG/1.5ML(40MG/ML) Injectable; Subcutaneous Prescription None No No
ALHEMO CONCIZUMAB-MTCI 150MG/1.5ML(100MG/ML) Injectable; Subcutaneous Prescription None No No
ALHEMO CONCIZUMAB-MTCI 300MG/3ML(100MG/ML) Injectable; Subcutaneous 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
12/20/2024 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761315s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761315Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761315Orig1s000TOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/20/2024 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761315s000lbl.pdf
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