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Ryplazim
plasminogen, human-tvmh
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Ryplazim
Proper name
plasminogen, human-tvmh
Licence type
351(a)
BLA number
125659
Applicant
Kedrion Biopharma Inc.
Center
CBER
Presentations
1
First licensure
June 4, 2021
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 68.8MG | For Injection | Intravenous | Single-Dose Vial | Rx | June 4, 2021 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | June 4, 2028 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |