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Xigris
drotrecogin alfa
351(a) Standalone BLA
Overview
Source: Purple BookProprietary 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| 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 |