Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 103767
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://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
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
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

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