On this page
TNKase
tenecteplase
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
TNKase
Proper name
tenecteplase
Licence type
351(a)
BLA number
103909
Applicant
Genentech, Inc.
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 25MG | For Injection | Intravenous | Single-Dose Vial | Rx | February 28, 2025 |
| 50MG | For Injection | Intravenous | Single-Dose Vial | Rx | June 2, 2000 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |