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Recothrom
Thrombin topical (Recombinant)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Recothrom
Proper name
Thrombin topical (Recombinant)
Licence type
351(a)
BLA number
125248
Applicant
Baxter Healthcare Corporation
Center
CBER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 20000IU | For Solution | Topical | Single-Dose Vial | Rx | May 23, 2008 |
| 5000IU | For Solution | Topical | Single-Dose Vial | Rx | January 17, 2008 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |