Purple Book product · Reference 351(a)
Autoplex, Feiba Nf, Feiba Vh
Anti-Inhibitor Coagulant Complex
Jul 31, 2000
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.
Jul 31, 2000
26 yr 4 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Dec 16, 2020
5 yr 8 mo ago
Today
Pharmaceutical detail
Strength
500U
Dosage form
For Injection
Route
Intravenous
Presentation
Bottle
Center
CBER
License number
1898
Product number
004
Submission type
Supplement
Supplement number
1029
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.
4 additional BLA records 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
- advanced-searchAdvanced Search · Jul 02, 2026
- monthly-downloadMonthly download · Jul 02, 2026
Change history
- v6Jul 02, 2026
- v5Jul 02, 2026
- v4Jul 02, 2026
- v3Jul 02, 2026
- v2Jul 02, 2026
Frequently asked questions
Does Autoplex, Feiba Nf, Feiba Vh have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Autoplex, Feiba Nf, Feiba Vh are listed in the FDA Purple Book yet.
What is Autoplex, Feiba Nf, Feiba Vh's BLA number?
Autoplex, Feiba Nf, Feiba Vh is licensed under BLA 101447, held by Takeda Pharmaceuticals U.S.A., Inc..
When was Autoplex, Feiba Nf, Feiba Vh approved by the FDA?
Autoplex, Feiba Nf, Feiba Vh was approved by the FDA on Jul 31, 2000.
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.
