Purple Book product · Reference 351(a)
Trasylol
aprotinin
Dec 29, 1993
Approved
Reference 351(a)
License type
Disc
Marketing
None
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Approval
Approval date of this BLA submission.
Dec 29, 1993
33 yr ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Dec 29, 2000
25 yr 11 mo ago
Today
Pharmaceutical detail
Strength
1,000,000KIU/100ML (10,000KIU/ML)
Dosage form
Injection
Route
Intravenous
Presentation
Single-Dose Vial
Center
CDER
License number
1778
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.
1 additional BLA record for this product (other strengths or presentations) are in the same reference family.
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
- monthly-downloadMonthly download · Jul 02, 2026
Change history
- v1Jul 02, 2026
Frequently asked questions
Does Trasylol have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Trasylol are listed in the FDA Purple Book yet.
What is Trasylol's BLA number?
Trasylol is licensed under BLA 20304, held by Bayer HealthCare Pharmaceuticals Inc..
When was Trasylol approved by the FDA?
Trasylol was approved by the FDA on Dec 29, 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.
