Purple Book product · Reference 351(a)
Thrombin-Jmi, Thrombocoll
Thrombin, Topical (Bovine)
Feb 03, 1986
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 03, 1986
41 yr ago
Today
Pharmaceutical detail
Strength
20,000IU
Dosage form
Powder
Route
Topical
Presentation
Vial
Center
CBER
License number
0977
Product number
001
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.
3 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 Thrombin-Jmi, Thrombocoll have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Thrombin-Jmi, Thrombocoll are listed in the FDA Purple Book yet.
What is Thrombin-Jmi, Thrombocoll's BLA number?
Thrombin-Jmi, Thrombocoll is licensed under BLA 102865, held by GenTrac, Inc..
When was Thrombin-Jmi, Thrombocoll approved by the FDA?
Thrombin-Jmi, Thrombocoll was approved by the FDA on Feb 03, 1986.
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.
