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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761112
Company: ABLYNX NV
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CABLIVI CAPLACIZUMAB-YHDP 11MG/VIAL 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
02/06/2019 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761112Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761112Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761112Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/23/2022 SUPPL-9 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761112s009lbl.pdf
12/16/2020 SUPPL-7 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761112s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761112Orig1s007ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/23/2022 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761112s009lbl.pdf
12/16/2020 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761112s007lbl.pdf
02/06/2019 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761112Orig1s000ltr.pdf
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