On this page
Pulmozyme
dornase alfa
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Pulmozyme
Proper name
dornase alfa
Licence type
351(a)
BLA number
103532
Applicant
Genentech, Inc.
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 2.5MG/2.5ML (1MG/ML) | Solution | Inhalation | Ampule | Rx | December 30, 1993 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | December 30, 2000 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |