Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125399
Company: SEATTLE GENETICS
Company: SEATTLE GENETICS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ADCETRIS | BRENTUXIMAB VEDOTIN | 50MG/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 |
---|---|---|---|---|---|---|---|
08/19/2011 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125388s000,125399s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125388s000,125399s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125399_adcetris_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125399Orig1s000SumR.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/19/2011 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125388s000,125399s000lbl.pdf |