Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761112
Company: ABLYNX NV
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 |
---|---|---|---|---|---|
10/30/2024 | SUPPL-13 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761112s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761112Orig1s013ltr.pdf | |
04/11/2024 | SUPPL-11 | Supplement |
Label (PDF)
Letter (PDF) Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761112s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761112Orig1s011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761112Orig1s011ltr.pdf | |
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 |
---|---|---|---|---|---|
10/30/2024 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761112s013lbl.pdf | |
04/11/2024 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761112s011lbl.pdf | |
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 |