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Actimmune

interferon gamma-1b

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Actimmune

Proper name

interferon gamma-1b

Licence type

351(a)

BLA number

103836

Applicant

Horizon Therapeutics Ireland DAC

Center

CDER

Presentations

1

First licensure

—

Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
100MCG(2MILLION INTERNATIONAL UNITS)/0.5ML	Injection	Subcutaneous	Single-Dose Vial	Rx	February 25, 1999

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	February 10, 2007

Sources for this page

Purple Book	FDA	Licence type, presentations, reference product, exclusivity