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Thrombin-Jmi, Thrombocoll
Thrombin, Topical (Bovine)
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Thrombin-Jmi, Thrombocoll
Proper name
Thrombin, Topical (Bovine)
Licence type
351(a)
BLA number
102865
Applicant
GenTrac, Inc.
Center
CBER
Presentations
4
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 20,000IU | Powder | Topical | Vial | Rx | February 3, 1986 |
| 20,000IU | Solution | Topical | Single-Dose Vial | Rx | April 10, 2026 |
| 5,000IU | Powder | Topical | Vial | Rx | February 10, 2011 |
| 5,000IU | Solution | Topical | Single-Dose Vial | Rx | April 10, 2026 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |