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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 103293
Company: CHIRON

Products on BLA 103293

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROLEUKIN	ALDESLEUKIN	22MIU/VIAL	VIAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 103293

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
09/29/2023	SUPPL-5154	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103293s51,54lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/103293Orig1s5154ltr.pdf
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.

Labels for BLA 103293

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/29/2023	SUPPL-5154	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103293s51,54lbl.pdf
07/30/2012	SUPPL-5130	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103293s5130lbl.pdf

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