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Mononine
Coagulation Factor IX (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Mononine
Proper name
Coagulation Factor IX (Human)
Licence type
351(a)
BLA number
103957
Applicant
CSL Behring LLC
Center
CBER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1000IU | For Injection | Intravenous | Single-Dose Vial | Disc | March 17, 2000 |
| 500IU | For Injection | Intravenous | Single-Dose Vial | Disc | March 17, 2000 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | August 20, 1999 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |