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FDA BLA · BLA103836

ACTIMMUNE

interferon gamma-1b

Sponsor: HORIZON THERAPEUTICS IRELAND DAC

APPLICATION
BLA103836
TYPE
BLA
ORIGINAL APPROVAL
1999-02-25
LATEST ACTION
2015-08-27
ROUTE
SUBCUTANEOUS, SINGLE-USE
DOSAGE FORM
VIAL
MARKETING STATUS
Prescription

Products

ACTIMMUNEPrescription
INTERFERON GAMMA-1B 100UG/0.5ML · VIAL · SINGLE-USE

Approval history

2015-08-27Labeling · Supplement 5182 · standard — Label ↗AP
2007-01-26Supplement · Supplement 5098 — Label ↗AP
2005-09-13Labeling · Supplement 5071 · standardAP
2004-11-24Labeling · Supplement 5050 · standard — Label ↗AP
2004-03-18Efficacy · Supplement 5033 · priorityAP
2003-05-09Labeling · Supplement 5017 · standardAP
2000-02-10Efficacy · Supplement 1001 · priority — Letter ↗AP
1999-02-25Type 1 - New Molecular Entity · Original · unknown — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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