Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761333
Company: AMGEN INC
Company: AMGEN INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BKEMV | ECULIZUMAB-AEEB | 300MG/30ML(10MG/ML) | 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 |
---|---|---|---|---|---|---|---|
05/28/2024 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761333s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761333Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
SUPPL-1 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761333s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761333Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/28/2024 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761333s000lbl.pdf | |
SUPPL-1 | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761333s001lbl.pdf |