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Xigris

drotrecogin alfa

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Xigris
Proper name
drotrecogin alfa
Licence type
351(a)
BLA number
125029
Applicant
Eli Lilly and Company
Center
CDER
Presentations
2
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
20MG Injection Intravenous Single-Dose Vial Disc November 21, 2001
5MG Injection Intravenous Single-Dose Vial Disc November 21, 2001

Sources for this page

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