Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 103767
Company: EISAI INC
Company: EISAI INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ONTAK | DENILEUKIN DIFTITOX | 150UG/ML | VIAL | 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 |
---|---|---|---|---|---|---|---|
02/05/1999 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/denser020599lb.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/denser020599L.htm https://web.archive.org/web/20120303004301/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080717.htm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/10/2020 | SUPPL-5144 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103767s5144lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/103767Orig1s5144ltr.pdf | |
02/15/2019 | SUPPL-5143 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103767s5143lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/103767Orig1s5143ltr.pdf | |
08/30/2011 | SUPPL-5119 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103767s5119lbl.pdf | |
03/05/2010 | SUPPL-5118 | Supplement |
Label is not available on this site. |
||
10/15/2008 | SUPPL-5094 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103767s5094lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103767s5094ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/10/2020 | SUPPL-5144 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103767s5144lbl.pdf | |
02/15/2019 | SUPPL-5143 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103767s5143lbl.pdf | |
08/30/2011 | SUPPL-5119 | Supplement | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103767s5119lbl.pdf | |
10/15/2008 | SUPPL-5094 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103767s5094lbl.pdf | |
02/05/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/denser020599lb.pdf |