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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 103836
Company: HORIZON THERAPEUTICS IRELAND DAC

Other Important Information from FDA

Products on BLA 103836

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACTIMMUNE	INTERFERON GAMMA-1B	100UG/0.5ML	VIAL; SINGLE-USE	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 103836

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/25/1999	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
08/27/2015	SUPPL-5182	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103836s5182lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103836Orig1s5182ltr.pdf
01/26/2007	SUPPL-5098	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103836s5098LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103836s5098ltr.pdf
09/13/2005	SUPPL-5071	Supplement		Label is not available on this site.
11/24/2004	SUPPL-5050	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103836_5050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103836_5050ltr.pdf
03/18/2004	SUPPL-5033	Supplement		Label is not available on this site.
05/09/2003	SUPPL-5017	Supplement		Label is not available on this site.
02/10/2000	SUPPL-1001	Supplement	Letter	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/inteint021000L.htm

Labels for BLA 103836

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/27/2015	SUPPL-5182	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103836s5182lbl.pdf
01/26/2007	SUPPL-5098	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103836s5098LBL.pdf
11/24/2004	SUPPL-5050	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103836_5050lbl.pdf

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