On this page
Cathflo Activase
alteplase
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Cathflo Activase
Proper name
alteplase
Licence type
351(a)
BLA number
103172
Applicant
Genentech, Inc.
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 2MG | For Injection | Intravenous | Single-Dose Vial | Rx | September 4, 2001 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |