Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 103293
Company: CHIRON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROLEUKIN ALDESLEUKIN 22MIU/VIAL 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
05/05/1992 ORIG-1 Approval N/A; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/17/2019 SUPPL-5146 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/103293Orig1s5146ltr.pdf
05/06/2015 SUPPL-5139 Supplement

Label is not available on this site.

07/30/2012 SUPPL-5130 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103293s5130lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103293Orig1s5130ltr.pdf
12/16/2011 SUPPL-5123 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103293s5123ltr.pdf
07/19/2011 SUPPL-5114 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103293s5114ltr.pdf
07/06/2010 SUPPL-5099 Supplement

Label is not available on this site.

03/17/2010 SUPPL-5088 Supplement

Label is not available on this site.

04/08/2009 SUPPL-5087 Supplement

Label is not available on this site.

06/27/2000 SUPPL-1029 Supplement

Label is not available on this site.

01/09/1998 SUPPL-1021 Supplement Letter
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/aldechi010998L.htm https://web.archive.org/web/20170113111500/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080733.htm
01/09/1998 SUPPL-1019 Supplement

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/30/2012 SUPPL-5130 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103293s5130lbl.pdf

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