Gonal-f RFF RediJect Purple Book BLA 021684
- BLA number
- 021684
- Proprietary names
- Gonal-f RFF RediJect
- Proper names
- follitropin alfa
- Applicant
- EMD Serono, Inc.
- 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 | Gonal-f RFF RediJect | follitropin alfa | 351(a) | 300IU/0.5ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2004-05-25 | |
| 002 | Gonal-f RFF RediJect | follitropin alfa | 351(a) | 450IU/0.75ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2004-05-25 | |
| 003 | Gonal-f RFF RediJect | follitropin alfa | 351(a) | 900IU/1.5ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2004-05-25 | |
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 |
|---|
| 2020-05-01 | R | 001 | Gonal-f RFF RediJect | 351(a) | Rx | EMD Serono, Inc. |
| 2020-05-01 | R | 002 | Gonal-f RFF RediJect | 351(a) | Rx | EMD Serono, Inc. |
| 2020-05-01 | R | 003 | Gonal-f RFF RediJect | 351(a) | Rx | EMD Serono, Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2020-05-01 | 001 | Gonal-f RFF RediJect | 351(a) | Rx | Licensed | 2004-05-25 |
| 2020-05-01 | 002 | Gonal-f RFF RediJect | 351(a) | Rx | Licensed | 2004-05-25 |
| 2020-05-01 | 003 | Gonal-f RFF RediJect | 351(a) | Rx | Licensed | 2004-05-25 |