Palforzia Purple Book BLA 125696
- BLA number
- 125696
- Proprietary names
- Palforzia
- Proper names
- Peanut (Arachis hypogaea) Allergen Powder-dnfp
- Applicant
- Greer Laboratories, 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 table| Product | Proprietary name | Proper name | License type | Strength | Dosage form | Route | Presentation | Marketing | Licensure | Approval | Patent list provided |
|---|
| 001 | Palforzia | Peanut (Arachis hypogaea) Allergen Powder-dnfp | 351(a) | 0.5MG | Powder | Oral | Capsule | Rx | Licensed | 2020-01-31 | |
| 002 | Palforzia | Peanut (Arachis hypogaea) Allergen Powder-dnfp | 351(a) | 1MG | Powder | Oral | Capsule | Rx | Licensed | 2020-01-31 | |
| 003 | Palforzia | Peanut (Arachis hypogaea) Allergen Powder-dnfp | 351(a) | 10MG | Powder | Oral | Capsule | Rx | Licensed | 2020-01-31 | |
| 004 | Palforzia | Peanut (Arachis hypogaea) Allergen Powder-dnfp | 351(a) | 20MG | Powder | Oral | Capsule | Rx | Licensed | 2020-01-31 | |
| 005 | Palforzia | Peanut (Arachis hypogaea) Allergen Powder-dnfp | 351(a) | 100MG | Powder | Oral | Capsule | Rx | Licensed | 2020-01-31 | |
| 006 | Palforzia | Peanut (Arachis hypogaea) Allergen Powder-dnfp | 351(a) | 300MG | Powder | Oral | Sachet | Rx | Licensed | 2020-01-31 | |
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 |
|---|
| 2025-03-01 | U | 001 | Palforzia | 351(a) | Rx | Greer Laboratories, Inc. |
| 2025-03-01 | U | 002 | Palforzia | 351(a) | Rx | Greer Laboratories, Inc. |
| 2025-03-01 | U | 003 | Palforzia | 351(a) | Rx | Greer Laboratories, Inc. |
| 2025-03-01 | U | 004 | Palforzia | 351(a) | Rx | Greer Laboratories, Inc. |
| 2025-03-01 | U | 005 | Palforzia | 351(a) | Rx | Greer Laboratories, Inc. |
| 2025-03-01 | U | 006 | Palforzia | 351(a) | Rx | Greer Laboratories, Inc. |
| 2022-05-01 | U | 001 | Palforzia | 351(a) | Rx | Aimmune Therapeutics, Inc. |
| 2022-05-01 | U | 002 | Palforzia | 351(a) | Rx | Aimmune Therapeutics, Inc. |
| 2022-05-01 | U | 003 | Palforzia | 351(a) | Rx | Aimmune Therapeutics, Inc. |
| 2022-05-01 | U | 004 | Palforzia | 351(a) | Rx | Aimmune Therapeutics, Inc. |
| 2022-05-01 | U | 005 | Palforzia | 351(a) | Rx | Aimmune Therapeutics, Inc. |
| 2022-05-01 | U | 006 | Palforzia | 351(a) | Rx | Aimmune Therapeutics, Inc. |
| 2021-05-01 | U | 001 | Palforzia | 351(a) | Rx | Aimmune Therapeutics, Inc. |
| 2021-05-01 | N | 002 | Palforzia | 351(a) | Rx | Aimmune Therapeutics, Inc. |
| 2021-05-01 | N | 003 | Palforzia | 351(a) | Rx | Aimmune Therapeutics, Inc. |
| 2021-05-01 | N | 004 | Palforzia | 351(a) | Rx | Aimmune Therapeutics, Inc. |
| 2021-05-01 | N | 005 | Palforzia | 351(a) | Rx | Aimmune Therapeutics, Inc. |
| 2021-05-01 | N | 006 | Palforzia | 351(a) | Rx | Aimmune Therapeutics, Inc. |
| 2020-08-01 | N | 001 | Palforzia | 351(a) | Rx | Aimmune Therapeutics, Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2022-05-01 | 001 | Palforzia | 351(a) | Rx | Licensed | 2020-01-31 |
| 2022-05-01 | 002 | Palforzia | 351(a) | Rx | Licensed | 2020-01-31 |
| 2022-05-01 | 003 | Palforzia | 351(a) | Rx | Licensed | 2020-01-31 |
| 2022-05-01 | 004 | Palforzia | 351(a) | Rx | Licensed | 2020-01-31 |
| 2022-05-01 | 005 | Palforzia | 351(a) | Rx | Licensed | 2020-01-31 |
| 2022-05-01 | 006 | Palforzia | 351(a) | Rx | Licensed | 2020-01-31 |
| 2021-05-01 | 002 | Palforzia | 351(a) | Rx | Licensed | 2020-01-31 |
| 2021-05-01 | 003 | Palforzia | 351(a) | Rx | Licensed | 2020-01-31 |
| 2021-05-01 | 004 | Palforzia | 351(a) | Rx | Licensed | 2020-01-31 |
| 2021-05-01 | 005 | Palforzia | 351(a) | Rx | Licensed | 2020-01-31 |
| 2021-05-01 | 006 | Palforzia | 351(a) | Rx | Licensed | 2020-01-31 |
| 2020-08-01 | 001 | Palforzia | 351(a) | Rx | Licensed | 2020-01-31 |