Purple Book product · Reference 351(a)
Coagadex
Coagulation Factor X (Human)
Oct 20, 2015
Approved
Reference 351(a)
License type
Rx
Marketing
None
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Apr 14, 1930
97 yr 8 mo ago
Approval
Approval date of this BLA submission.
Oct 20, 2015
10 yr 11 mo ago
Today
Pharmaceutical detail
Strength
250IU
Dosage form
For Injection
Route
Intravenous
Presentation
Single-Dose Vial
Center
CBER
License number
1811
Product number
002
Submission type
Original
Supplement number
0
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.
1 additional BLA record 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
- v4Jul 02, 2026
- v3Jul 02, 2026
- v2Jul 02, 2026
Frequently asked questions
Does Coagadex have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Coagadex are listed in the FDA Purple Book yet.
What is Coagadex's BLA number?
Coagadex is licensed under BLA 125506, held by Bio Products Laboratory Limited.
When was Coagadex approved by the FDA?
Coagadex was approved by the FDA on Oct 20, 2015.
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.
