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Proplex-T; Bebulin
Factor IX Complex
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Proplex-T; Bebulin
Proper name
Factor IX Complex
Licence type
351(a)
BLA number
103112
Applicant
Baxalta US Inc.
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 200-1200U/20ML | For Injection | Intravenous | Vial | Rx | August 21, 1970 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |