Purple Book product · Reference 351(a)
Acthrel
corticorelin ovine triflutate
May 23, 1996
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.
May 23, 1996
30 yr 7 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
May 23, 2003
23 yr 6 mo ago
Today
Pharmaceutical detail
Strength
100MCG
Dosage form
For Injection
Route
Intravenous
Presentation
Single-Dose Vial
Center
CDER
License number
2112
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
- monthly-downloadMonthly download · Jul 02, 2026
Change history
- v2Jul 02, 2026
- v1Jul 02, 2026
Frequently asked questions
Does Acthrel have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Acthrel are listed in the FDA Purple Book yet.
What is Acthrel's BLA number?
Acthrel is licensed under BLA 20162, held by Ferring Pharmaceuticals Inc..
When was Acthrel approved by the FDA?
Acthrel was approved by the FDA on May 23, 1996.
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.
