Purple Book product · Reference 351(a)
Ontak
denileukin diftitox
Feb 05, 1999
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.
Feb 05, 1999
27 yr 10 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Feb 05, 2006
20 yr 9 mo ago
Today
Pharmaceutical detail
Strength
150MCG/ML (300MCG/2ML)
Dosage form
Injection
Route
Intravenous
Presentation
Single-Dose Vial
Center
CDER
License number
1862
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 Ontak have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Ontak are listed in the FDA Purple Book yet.
What is Ontak's BLA number?
Ontak is licensed under BLA 103767, held by Eisai, Incorporated.
When was Ontak approved by the FDA?
Ontak was approved by the FDA on Feb 05, 1999.
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.
