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Hemofil M
Antihemophilic Factor (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Hemofil M
Proper name
Antihemophilic Factor (Human)
Licence type
351(a)
BLA number
101448
Applicant
Takeda Pharmaceuticals U.S.A., Inc.
Center
CBER
Presentations
4
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1000IU | For Injection | Intravenous | Single-Dose Vial | Rx | March 14, 2001 |
| 1700IU | For Injection | Intravenous | Single-Dose Vial | Rx | March 14, 2001 |
| 250IU | For Injection | Intravenous | Single-Dose Vial | Rx | March 14, 2001 |
| 500IU | For Injection | Intravenous | Single-Dose Vial | Rx | March 14, 2001 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |