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Evithrom
Thrombin, Topical (Human)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Evithrom
Proper name
Thrombin, Topical (Human)
Licence type
351(a)
BLA number
125247
Applicant
Omrix Biopharmaceuticals Ltd
Center
CBER
Presentations
4
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1600-2400IU/ML | For Injection | Topical | Single-dose vial | Rx | September 17, 2009 |
| 20ML IU/ML | Solution | Topical | Single-Dose Vial | Disc | August 27, 2007 |
| 2ML IU/ML | Solution | Topical | Single-Dose Vial | Disc | August 27, 2007 |
| 5ML IU/ML | Solution | Topical | Single-Dose Vial | Disc | August 27, 2007 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |