Gammaked, Gamunex-C Purple Book BLA 125046
- BLA number
- 125046
- Proprietary names
- Gammaked, Gamunex-C
- Proper names
- Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified
- Applicant
- Grifols Therapeutics LLC
- Center
- CBER
- First observed release
- 2020-08-01
- Latest observed release
- 2026-06-01
- Newest archive release
- 2026-06-01
- FDA patent list
- No patents listed in the captured FDA patent list; source updated 2025-06-11
- Coverage
- Present in newest release
Latest Known Product Presentations#
Product, Proprietary name, Proper name table| Product | Proprietary name | Proper name | License type | Strength | Dosage form | Route | Presentation | Marketing | Licensure | Approval | Patent list provided |
|---|
| 001 | Gammaked, Gamunex-C | Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified | 351(a) | 2.5G/25ML | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | 2003-08-27 | |
| 002 | Gammaked, Gamunex-C | Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified | 351(a) | 5G/50ML | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | 2003-08-27 | |
| 003 | Gammaked, Gamunex-C | Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified | 351(a) | 10G/100ML | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | 2003-08-27 | |
| 004 | Gammaked, Gamunex-C | Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified | 351(a) | 1G/10ML | Injection | Intravenous | Bottle | Rx | Licensed | 2003-08-27 | |
| 005 | Gammaked, Gamunex-C | Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified | 351(a) | 20G/200ML | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | 2003-08-27 | |
| 006 | Gammaked, Gamunex-C | Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified | 351(a) | 40G/400ML | Injection | Intravenous | Single-Use Bottle | Rx | Licensed | 2003-08-27 | |
| 007 | Gammaked, Gamunex-C | Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified | 351(a) | 2.5G/25ML | Injection | Subcutaneous | Single-Use Bottle | Rx | Licensed | 2003-08-27 | |
| 008 | Gammaked, Gamunex-C | Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified | 351(a) | 5G/50ML | Injection | Subcutaneous | Single-Use Bottle | Rx | Licensed | 2003-08-27 | |
| 009 | Gammaked, Gamunex-C | Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified | 351(a) | 10G/100ML | Injection | Subcutaneous | Single-Use Bottle | Rx | Licensed | 2003-08-27 | |
| 010 | Gammaked, Gamunex-C | Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified | 351(a) | 20G/200ML | Injection | Subcutaneous | Single-Use Bottle | Rx | Licensed | 2003-08-27 | |
| 011 | Gammaked, Gamunex-C | Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified | 351(a) | 40G/400ML | Injection | Subcutaneous | Single-Use Bottle | Rx | Licensed | 2003-08-27 | |
| 012 | Gammaked, Gamunex-C | Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified | 351(a) | 40G/400ML | Injection | Intravenous | Bag | Rx | Licensed | 2025-10-20 | |
| 013 | Gammaked, Gamunex-C | Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified | 351(a) | 20G/200ML | Injection | Intravenous | Bag | Rx | Licensed | 2025-10-20 | |
| 014 | Gammaked, Gamunex-C | Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified | 351(a) | 10G/100ML | Injection | Intravenous | Bag | Rx | Licensed | 2025-10-20 | |
| 015 | Gammaked, Gamunex-C | Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified | 351(a) | 5G/50ML | Injection | Intravenous | Bag | Rx | Licensed | 2025-10-20 | |
| 016 | Gammaked, Gamunex-C | Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified | 351(a) | 40G/400ML | Injection | Subcutaneous | Bag | Rx | Licensed | 2025-10-20 | |
| 017 | Gammaked, Gamunex-C | Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified | 351(a) | 20G/200ML | Injection | Subcutaneous | Bag | Rx | Licensed | 2025-10-20 | |
| 018 | Gammaked, Gamunex-C | Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified | 351(a) | 10G/100ML | Injection | Subcutaneous | Bag | Rx | Licensed | 2025-10-20 | |
| 019 | Gammaked, Gamunex-C | Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified | 351(a) | 5G/50ML | Injection | Subcutaneous | Bag | Rx | Licensed | 2025-10-20 | |
Published Patent List#
No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.
Official Monthly Change Events#
Release, Event, Product table| Release | Event | Product | Name | License type | Status | Applicant |
|---|
| 2026-05-01 | U | 001 | Gammaked, Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2026-05-01 | U | 002 | Gammaked, Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2026-05-01 | U | 003 | Gammaked, Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2026-05-01 | U | 004 | Gammaked, Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2026-05-01 | U | 005 | Gammaked, Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2026-05-01 | U | 006 | Gammaked, Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2026-05-01 | U | 007 | Gammaked, Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2026-05-01 | U | 008 | Gammaked, Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2026-05-01 | U | 009 | Gammaked, Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2026-05-01 | U | 010 | Gammaked, Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2026-05-01 | U | 011 | Gammaked, Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2026-05-01 | N | 012 | Gammaked, Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2026-05-01 | N | 013 | Gammaked, Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2026-05-01 | N | 014 | Gammaked, Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2026-05-01 | N | 015 | Gammaked, Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2026-05-01 | N | 016 | Gammaked, Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2026-05-01 | N | 017 | Gammaked, Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2026-05-01 | N | 018 | Gammaked, Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2026-05-01 | N | 019 | Gammaked, Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2023-06-01 | U | 001 | Gammaked, Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2023-06-01 | U | 002 | Gammaked, Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2023-06-01 | U | 003 | Gammaked, Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2023-06-01 | U | 004 | Gammaked, Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2023-06-01 | U | 005 | Gammaked, Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2023-06-01 | U | 006 | Gammaked, Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2023-06-01 | U | 007 | Gammaked, Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2023-06-01 | U | 008 | Gammaked, Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2023-06-01 | U | 009 | Gammaked, Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2023-06-01 | U | 010 | Gammaked, Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2023-06-01 | U | 011 | Gammaked, Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2023-02-01 | U | 001 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2023-02-01 | U | 002 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2023-02-01 | U | 003 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2023-02-01 | U | 004 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2023-02-01 | U | 005 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2023-02-01 | U | 006 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2023-02-01 | U | 007 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2023-02-01 | U | 008 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2023-02-01 | U | 009 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2023-02-01 | U | 010 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2023-02-01 | U | 011 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2022-01-01 | U | 001 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2022-01-01 | U | 002 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2022-01-01 | U | 003 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2022-01-01 | U | 005 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2022-01-01 | U | 006 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2022-01-01 | U | 007 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2022-01-01 | U | 008 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2022-01-01 | U | 009 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2022-01-01 | U | 010 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2022-01-01 | U | 011 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2021-05-01 | U | 001 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2021-05-01 | U | 002 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2021-05-01 | U | 003 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2021-05-01 | U | 004 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2021-05-01 | U | 005 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2021-05-01 | U | 006 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2020-08-01 | R | 001 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2020-08-01 | R | 002 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2020-08-01 | R | 003 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2020-08-01 | R | 004 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2020-08-01 | R | 005 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
| 2020-08-01 | R | 006 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Grifols Therapeutics LLC |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2026-05-01 | 012 | Gammaked, Gamunex-C | 351(a) | Rx | Licensed | 2025-10-20 |
| 2026-05-01 | 013 | Gammaked, Gamunex-C | 351(a) | Rx | Licensed | 2025-10-20 |
| 2026-05-01 | 014 | Gammaked, Gamunex-C | 351(a) | Rx | Licensed | 2025-10-20 |
| 2026-05-01 | 015 | Gammaked, Gamunex-C | 351(a) | Rx | Licensed | 2025-10-20 |
| 2026-05-01 | 016 | Gammaked, Gamunex-C | 351(a) | Rx | Licensed | 2025-10-20 |
| 2026-05-01 | 017 | Gammaked, Gamunex-C | 351(a) | Rx | Licensed | 2025-10-20 |
| 2026-05-01 | 018 | Gammaked, Gamunex-C | 351(a) | Rx | Licensed | 2025-10-20 |
| 2026-05-01 | 019 | Gammaked, Gamunex-C | 351(a) | Rx | Licensed | 2025-10-20 |
| 2023-06-01 | 001 | Gammaked, Gamunex-C | 351(a) | Rx | Licensed | 2003-08-27 |
| 2023-06-01 | 002 | Gammaked, Gamunex-C | 351(a) | Rx | Licensed | 2003-08-27 |
| 2023-06-01 | 003 | Gammaked, Gamunex-C | 351(a) | Rx | Licensed | 2003-08-27 |
| 2023-06-01 | 004 | Gammaked, Gamunex-C | 351(a) | Rx | Licensed | 2003-08-27 |
| 2023-06-01 | 005 | Gammaked, Gamunex-C | 351(a) | Rx | Licensed | 2003-08-27 |
| 2023-06-01 | 006 | Gammaked, Gamunex-C | 351(a) | Rx | Licensed | 2003-08-27 |
| 2023-06-01 | 007 | Gammaked, Gamunex-C | 351(a) | Rx | Licensed | 2003-08-27 |
| 2023-06-01 | 008 | Gammaked, Gamunex-C | 351(a) | Rx | Licensed | 2003-08-27 |
| 2023-06-01 | 009 | Gammaked, Gamunex-C | 351(a) | Rx | Licensed | 2003-08-27 |
| 2023-06-01 | 010 | Gammaked, Gamunex-C | 351(a) | Rx | Licensed | 2003-08-27 |
| 2023-06-01 | 011 | Gammaked, Gamunex-C | 351(a) | Rx | Licensed | 2003-08-27 |
| 2022-01-01 | 007 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Licensed | 2003-08-27 |
| 2022-01-01 | 008 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Licensed | 2003-08-27 |
| 2022-01-01 | 009 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Licensed | 2003-08-27 |
| 2022-01-01 | 010 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Licensed | 2003-08-27 |
| 2022-01-01 | 011 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Licensed | 2003-08-27 |
| 2020-08-01 | 001 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Licensed | 2003-08-27 |
| 2020-08-01 | 002 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Licensed | 2003-08-27 |
| 2020-08-01 | 003 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Licensed | 2003-08-27 |
| 2020-08-01 | 004 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Licensed | 2003-08-27 |
| 2020-08-01 | 005 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Licensed | 2003-08-27 |
| 2020-08-01 | 006 | Gammaked (Kendrion), Gamunex-C | 351(a) | Rx | Licensed | 2003-08-27 |