Purple Book product · Reference 351(a)
Danyelza
naxitamab-gqgk
Nov 25, 2020
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.
Nov 25, 2020
5 yr 9 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Nov 25, 2027
in 1 yr 5 mo
Pharmaceutical detail
Strength
40MG/10ML (4MG/ML)
Dosage form
Injection
Route
Intravenous
Presentation
Single-Dose Vial
Center
CDER
License number
2209
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 Danyelza have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Danyelza are listed in the FDA Purple Book yet.
What is Danyelza's BLA number?
Danyelza is licensed under BLA 761171, held by Y-mABs Therapeutics, Inc.
When was Danyelza approved by the FDA?
Danyelza was approved by the FDA on Nov 25, 2020.
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.
