Purple Book product · Reference 351(a)
Hepagam B
Hepatitis B Immune Globulin (Human)
Jan 27, 2006
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.
Jan 27, 2006
20 yr 9 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Apr 06, 2014
12 yr 6 mo ago
Today
Pharmaceutical detail
Strength
>312IU/ML
Dosage form
Injection
Route
Intramuscular
Presentation
Single-Dose Vial
Center
CBER
License number
1826
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
- v5Jul 02, 2026
- v4Jul 02, 2026
- v3Jul 02, 2026
- v2Jul 02, 2026
Frequently asked questions
Does Hepagam B have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Hepagam B are listed in the FDA Purple Book yet.
What is Hepagam B's BLA number?
Hepagam B is licensed under BLA 125035, held by Kamada Ltd..
When was Hepagam B approved by the FDA?
Hepagam B was approved by the FDA on Jan 27, 2006.
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.
