Follistim AQ Cartridge Purple Book BLA 021211
- BLA number
- 021211
- Proprietary names
- Follistim AQ Cartridge
- Proper names
- follitropin beta
- Applicant
- Organon USA LLC, a subsidiary of Organon & Co.
- Center
- CDER
- First observed release
- 2020-05-01
- 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 | Follistim AQ Cartridge | follitropin beta | 351(a) | 300IU/0.36ML | Injection | Subcutaneous | Multi-Dose Cartridge | Rx | Licensed | 2004-03-23 | |
| 002 | Follistim AQ Cartridge | follitropin beta | 351(a) | 600IU/0.72ML | Injection | Subcutaneous | Multi-Dose Cartridge | Rx | Licensed | 2004-03-23 | |
| 003 | Follistim AQ Cartridge | follitropin beta | 351(a) | 175IU/0.21ML | Injection | Subcutaneous | Multi-Dose Cartridge | Disc | Voluntarily Revoked | 2005-02-11 | |
| 004 | Follistim AQ Cartridge | follitropin beta | 351(a) | 900IU/1.08ML | Injection | Subcutaneous | Multi-Dose Cartridge | Rx | Licensed | 2005-02-11 | |
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 |
|---|
| 2026-04-01 | U | 003 | Follistim AQ Cartridge | 351(a) | Disc | Organon USA LLC, a subsidiary of Organon & Co. |
| 2023-09-01 | U | 001 | Follistim AQ Cartridge | 351(a) | Rx | Organon USA LLC, a subsidiary of Organon & Co. |
| 2023-09-01 | U | 002 | Follistim AQ Cartridge | 351(a) | Rx | Organon USA LLC, a subsidiary of Organon & Co. |
| 2023-09-01 | U | 003 | Follistim AQ Cartridge | 351(a) | Disc | Organon USA LLC, a subsidiary of Organon & Co. |
| 2023-09-01 | U | 004 | Follistim AQ Cartridge | 351(a) | Rx | Organon USA LLC, a subsidiary of Organon & Co. |
| 2023-08-01 | U | 001 | Follistim AQ Cartridge | 351(a) | Rx | Organon USA LLC, a subsidiary of Organon & Co. |
| 2023-08-01 | U | 002 | Follistim AQ Cartridge | 351(a) | Rx | Organon USA LLC, a subsidiary of Organon & Co. |
| 2023-08-01 | U | 003 | Follistim AQ Cartridge | 351(a) | Disc | Organon USA LLC, a subsidiary of Organon & Co. |
| 2023-08-01 | U | 004 | Follistim AQ Cartridge | 351(a) | Rx | Organon USA LLC, a subsidiary of Organon & Co. |
| 2023-03-01 | U | 001 | Follistim AQ Cartridge | 351(a) | Rx | Organon USA Inc., a subsidiary of Merck & Co., Inc. |
| 2023-03-01 | U | 002 | Follistim AQ Cartridge | 351(a) | Rx | Organon USA Inc., a subsidiary of Merck & Co., Inc. |
| 2023-03-01 | U | 004 | Follistim AQ Cartridge | 351(a) | Rx | Organon USA Inc., a subsidiary of Merck & Co., Inc. |
| 2021-09-01 | U | 003 | Follistim AQ Cartridge | 351(a) | Disc | Organon USA Inc., a subsidiary of Merck & Co., Inc. |
| 2020-05-01 | R | 001 | Follistim AQ Cartridge | 351(a) | Rx | Organon USA Inc., a subsidiary of Merck & Co., Inc. |
| 2020-05-01 | R | 002 | Follistim AQ Cartridge | 351(a) | Rx | Organon USA Inc., a subsidiary of Merck & Co., Inc. |
| 2020-05-01 | R | 003 | Follistim AQ Cartridge | 351(a) | Rx | Organon USA Inc., a subsidiary of Merck & Co., Inc. |
| 2020-05-01 | R | 004 | Follistim AQ Cartridge | 351(a) | Rx | Organon USA Inc., a subsidiary of Merck & Co., Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2026-04-01 | 003 | Follistim AQ Cartridge | 351(a) | Disc | Voluntarily Revoked | 2005-02-11 |
| 2021-09-01 | 003 | Follistim AQ Cartridge | 351(a) | Disc | Licensed | 2005-02-11 |
| 2021-08-01 | 001 | Follistim AQ Cartridge | 351(a) | Rx | Licensed | 2004-03-23 |
| 2021-07-01 | 001 | Nikia Morris; cover letter from 5/7/21 submission | 351(a) | Rx | Licensed | 2004-03-23 |
| 2020-05-01 | 001 | Follistim AQ Cartridge | 351(a) | Rx | Licensed | 2004-03-23 |
| 2020-05-01 | 002 | Follistim AQ Cartridge | 351(a) | Rx | Licensed | 2004-03-23 |
| 2020-05-01 | 003 | Follistim AQ Cartridge | 351(a) | Rx | Licensed | 2005-02-11 |
| 2020-05-01 | 004 | Follistim AQ Cartridge | 351(a) | Rx | Licensed | 2005-02-11 |