Product Details for: Xigris
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
5MG
Single-Dose Vial
351(a)
Xigris
Disc
002
Injection
Intravenous
20MG
Single-Dose Vial
351(a)
Xigris
Disc
Proper Name
drotrecogin alfa
drotrecogin alfa
BLA Number
125029
125029
Applicant
Eli Lilly and Company
Eli Lilly and Company
Original Approval Date
November 21, 2001
November 21, 2001
Date of First Licensure