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Autoplex, Feiba Nf, Feiba Vh
Anti-Inhibitor Coagulant Complex
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Autoplex, Feiba Nf, Feiba Vh
Proper name
Anti-Inhibitor Coagulant Complex
Licence type
351(a)
BLA number
101447
Applicant
Takeda Pharmaceuticals U.S.A., Inc.
Center
CBER
Presentations
5
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1000IU | For Injection | Intravenous | Bottle | Disc | December 21, 1979 |
| 1000U | For Injection | Intravenous | Single-Dose Vial | Rx | July 31, 2000 |
| 2500U | For Injection | Intravenous | Single-Dose Vial | Rx | August 11, 2005 |
| 500IU | For Injection | Intravenous | Bottle | Disc | December 21, 1979 |
| 500U | For Injection | Intravenous | Bottle | Rx | July 31, 2000 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | December 16, 2020 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |