Gammagard, Gammagard S/D, Iveegam Purple Book BLA 103133
- BLA number
- 103133
- Proprietary names
- Gammagard, Gammagard S/D, Iveegam
- Proper names
- Immune Globulin Intravenous (Human)
- Applicant
- Takeda Pharmaceuticals U.S.A., Inc.
- 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 | License type | Strength | Dosage form | Route | Presentation | Marketing | Licensure | Approval | Patent list provided |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 001 | Gammagard, Gammagard S/D, Iveegam | Immune Globulin Intravenous (Human) | 351(a) | 0.5G | For Injection | Intravenous | Single-Use Bottle | Disc | Licensed | 1986-02-18 | |
| 002 | Gammagard, Gammagard S/D, Iveegam | Immune Globulin Intravenous (Human) | 351(a) | 1000MG | For Injection | Intravenous | Single-Use Bottle | Disc | Licensed | 1986-02-18 | |
| 003 | Gammagard, Gammagard S/D, Iveegam | Immune Globulin Intravenous (Human) | 351(a) | 2500MG | For Injection | Intravenous | Single-Use Bottle | Disc | Licensed | 1986-02-18 | |
| 004 | Gammagard, Gammagard S/D, Iveegam | Immune Globulin Intravenous (Human) | 351(a) | 500MG | For Injection | Intravenous | Single-Use Bottle | Disc | Licensed | 1986-02-18 | |
| 005 | Gammagard, Gammagard S/D, Iveegam | Immune Globulin Intravenous (Human) | 351(a) | 5000MG | For Injection | Intravenous | Single-Use Bottle | Disc | Licensed | 1986-02-18 | |
| 006 | Gammagard, Gammagard S/D, Iveegam | Immune Globulin Intravenous (Human) | 351(a) | 10G | For Injection | Intravenous | Single-Use Bottle | Rx | Licensed | 2000-07-27 | |
| 007 | Gammagard, Gammagard S/D, Iveegam | Immune Globulin Intravenous (Human) | 351(a) | 2.5G | For Injection | Intravenous | Single-Use Bottle | Disc | Licensed | 2000-07-27 | |
| 008 | Gammagard, Gammagard S/D, Iveegam | Immune Globulin Intravenous (Human) | 351(a) | 5.0G | For Injection | Intravenous | Single-Use Bottle | Rx | Licensed | 2000-07-27 |
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 | Name | License type | Status | Applicant |
|---|---|---|---|---|---|---|
| 2023-05-01 | U | 001 | Gammagard, Gammagard S/D, Iveegam | 351(a) | Disc | Takeda Pharmaceuticals U.S.A., Inc. |
| 2023-05-01 | U | 002 | Gammagard, Gammagard S/D, Iveegam | 351(a) | Disc | Takeda Pharmaceuticals U.S.A., Inc. |
| 2023-05-01 | U | 003 | Gammagard, Gammagard S/D, Iveegam | 351(a) | Disc | Takeda Pharmaceuticals U.S.A., Inc. |
| 2023-05-01 | U | 004 | Gammagard, Gammagard S/D, Iveegam | 351(a) | Disc | Takeda Pharmaceuticals U.S.A., Inc. |
| 2023-05-01 | U | 005 | Gammagard, Gammagard S/D, Iveegam | 351(a) | Disc | Takeda Pharmaceuticals U.S.A., Inc. |
| 2023-05-01 | U | 006 | Gammagard, Gammagard S/D, Iveegam | 351(a) | Rx | Takeda Pharmaceuticals U.S.A., Inc. |
| 2023-05-01 | U | 007 | Gammagard, Gammagard S/D, Iveegam | 351(a) | Disc | Takeda Pharmaceuticals U.S.A., Inc. |
| 2023-05-01 | U | 008 | Gammagard, Gammagard S/D, Iveegam | 351(a) | Rx | Takeda Pharmaceuticals U.S.A., Inc. |
| 2022-01-01 | U | 001 | Gammagard, Gammagard S/D, Iveegam | 351(a) | Disc | Baxalta US Inc. |
| 2022-01-01 | U | 007 | Gammagard, Gammagard S/D, Iveegam | 351(a) | Disc | Baxalta US Inc. |
| 2021-05-01 | U | 001 | Gammagard, Gammagard S/D, Iveegam | 351(a) | Disc | Baxalta US Inc. |
| 2021-05-01 | U | 002 | Gammagard, Gammagard S/D, Iveegam | 351(a) | Disc | Baxalta US Inc. |
| 2021-05-01 | U | 003 | Gammagard, Gammagard S/D, Iveegam | 351(a) | Disc | Baxalta US Inc. |
| 2021-05-01 | U | 004 | Gammagard, Gammagard S/D, Iveegam | 351(a) | Disc | Baxalta US Inc. |
| 2021-05-01 | U | 005 | Gammagard, Gammagard S/D, Iveegam | 351(a) | Disc | Baxalta US Inc. |
| 2021-05-01 | U | 006 | Gammagard, Gammagard S/D, Iveegam | 351(a) | Rx | Baxalta US Inc. |
| 2021-05-01 | U | 007 | Gammagard, Gammagard S/D, Iveegam | 351(a) | Disc | Baxalta US Inc. |
| 2021-05-01 | U | 008 | Gammagard, Gammagard S/D, Iveegam | 351(a) | Rx | Baxalta US Inc. |
| 2020-08-01 | R | 001 | Gammagard, Gammagard S/D, Iveegam | 351(a) | Disc | Baxalta US Inc. |
| 2020-08-01 | R | 002 | Gammagard, Gammagard S/D, Iveegam | 351(a) | Disc | Baxalta US Inc. |
| 2020-08-01 | R | 003 | Gammagard, Gammagard S/D, Iveegam | 351(a) | Disc | Baxalta US Inc. |
| 2020-08-01 | R | 004 | Gammagard, Gammagard S/D, Iveegam | 351(a) | Disc | Baxalta US Inc. |
| 2020-08-01 | R | 005 | Gammagard, Gammagard S/D, Iveegam | 351(a) | Disc | Baxalta US Inc. |
| 2020-08-01 | R | 006 | Gammagard, Gammagard S/D, Iveegam | 351(a) | Rx | Baxalta US Inc. |
| 2020-08-01 | R | 007 | Gammagard, Gammagard S/D, Iveegam | 351(a) | Disc | Baxalta US Inc. |
| 2020-08-01 | R | 008 | Gammagard, Gammagard S/D, Iveegam | 351(a) | Rx | Baxalta US Inc. |
Observed Product State History#
| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|---|---|---|---|---|---|
| 2020-08-01 | 001 | Gammagard, Gammagard S/D, Iveegam | 351(a) | Disc | Licensed | 1986-02-18 |
| 2020-08-01 | 002 | Gammagard, Gammagard S/D, Iveegam | 351(a) | Disc | Licensed | 1986-02-18 |
| 2020-08-01 | 003 | Gammagard, Gammagard S/D, Iveegam | 351(a) | Disc | Licensed | 1986-02-18 |
| 2020-08-01 | 004 | Gammagard, Gammagard S/D, Iveegam | 351(a) | Disc | Licensed | 1986-02-18 |
| 2020-08-01 | 005 | Gammagard, Gammagard S/D, Iveegam | 351(a) | Disc | Licensed | 1986-02-18 |
| 2020-08-01 | 006 | Gammagard, Gammagard S/D, Iveegam | 351(a) | Rx | Licensed | 2000-07-27 |
| 2020-08-01 | 007 | Gammagard, Gammagard S/D, Iveegam | 351(a) | Disc | Licensed | 2000-07-27 |
| 2020-08-01 | 008 | Gammagard, Gammagard S/D, Iveegam | 351(a) | Rx | Licensed | 2000-07-27 |