Purple Book product · Reference 351(a)
Pulmozyme
dornase alfa
Dec 30, 1993
Approved
Reference 351(a)
License type
Rx
Marketing
None
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Approval
Approval date of this BLA submission.
Dec 30, 1993
33 yr ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Dec 30, 2000
25 yr 11 mo ago
Today
Pharmaceutical detail
Strength
2.5MG/2.5ML (1MG/ML)
Dosage form
Solution
Route
Inhalation
Presentation
Ampule
Center
CDER
License number
1048
Product number
001
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyThis is the reference (originator) product. No biosimilars or interchangeables reference it in the Purple Book yet.
Patent list
No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.
Source provenance
- advanced-searchAdvanced Search · Jul 02, 2026
- monthly-downloadMonthly download · Jul 02, 2026
Change history
- v4Jul 02, 2026
- v3Jul 02, 2026
- v2Jul 02, 2026
Frequently asked questions
Does Pulmozyme have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Pulmozyme are listed in the FDA Purple Book yet.
What is Pulmozyme's BLA number?
Pulmozyme is licensed under BLA 103532, held by Genentech, Inc..
When was Pulmozyme approved by the FDA?
Pulmozyme was approved by the FDA on Dec 30, 1993.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
