Purple Book product · Reference 351(a)
Oncaspar
pegaspargase
Feb 01, 1994
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.
Feb 01, 1994
32 yr 11 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Feb 01, 2001
25 yr 10 mo ago
Today
Pharmaceutical detail
Strength
3,750IU/5ML(750IU/ML)
Dosage form
Injection
Route
Intravenous, Intramuscular
Presentation
Single-Dose Vial
Center
CDER
License number
2125
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
- v3Jul 02, 2026
- v2Jul 02, 2026
Frequently asked questions
Does Oncaspar have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Oncaspar are listed in the FDA Purple Book yet.
What is Oncaspar's BLA number?
Oncaspar is licensed under BLA 103411, held by Servier Pharmaceuticals LLC.
When was Oncaspar approved by the FDA?
Oncaspar was approved by the FDA on Feb 01, 1994.
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.
