Purple Book product · Reference 351(a)
Gammaked, Gamunex-C
Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified
Oct 20, 2025
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.
Sep 12, 2015
11 yr ago
Approval
Approval date of this BLA submission.
Oct 20, 2025
9 mo ago
Today
Pharmaceutical detail
Strength
10G/100ML
Dosage form
Injection
Route
Subcutaneous
Presentation
Bag
Center
CBER
License number
1871
Product number
018
Submission type
Supplement
Supplement number
2129
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.
18 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
- v5Jul 02, 2026
- v4Jul 02, 2026
- v3Jul 02, 2026
- v2Jul 02, 2026
- v1Jul 02, 2026
Frequently asked questions
Does Gammaked, Gamunex-C have approved biosimilars?
No 351(k) biosimilars or interchangeable biosimilars referencing Gammaked, Gamunex-C are listed in the FDA Purple Book yet.
What is Gammaked, Gamunex-C's BLA number?
Gammaked, Gamunex-C is licensed under BLA 125046, held by Grifols Therapeutics LLC.
When was Gammaked, Gamunex-C approved by the FDA?
Gammaked, Gamunex-C was approved by the FDA on Oct 20, 2025.
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.
