Epogen/Procrit Purple Book BLA 103234
- BLA number
- 103234
- Proprietary names
- Epogen/Procrit, Procrit
- Proper names
- epoetin alfa
- Applicant
- Amgen Inc.
- Center
- CDER
- First observed release
- 2020-02-01
- 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 | Epogen/Procrit | epoetin alfa | 351(a) | 10,000UNITS/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | Licensed | 1989-06-01 | |
| 002 | Epogen/Procrit | epoetin alfa | 351(a) | 20,000UNITS/2ML (10,000UNITS/ML) | Injection | Intravenous, Subcutaneous | Multi-Dose Vial | Rx | Licensed | | |
| 003 | Epogen/Procrit | epoetin alfa | 351(a) | 20,000UNITS/ML | Injection | Intravenous, Subcutaneous | Multi-Dose Vial | Rx | Licensed | | |
| 004 | Epogen/Procrit | epoetin alfa | 351(a) | 2,000UNITS/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | Licensed | 1989-06-01 | |
| 005 | Epogen/Procrit | epoetin alfa | 351(a) | 3,000UNITS/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | Licensed | 1989-06-01 | |
| 006 | Procrit | epoetin alfa | 351(a) | 40,000UNITS/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | Licensed | | |
| 007 | Epogen/Procrit | epoetin alfa | 351(a) | 4,000UNITS/ML | Injection | Intravenous, Subcutaneous | Single-Dose Vial | Rx | Licensed | 1989-06-01 | |
Biosimilar And Interchangeable Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125545 | Retacrit | epoetin alfa-epbx | 351(k) Biosimilar | Rx | 2026-06-01 |
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 |
|---|
| 2020-10-01 | U | 001 | Epogen/Procrit | 351(a) | Rx | Amgen, Inc. |
| 2020-10-01 | U | 002 | Epogen/Procrit | 351(a) | Rx | Amgen, Inc. |
| 2020-10-01 | U | 003 | Epogen/Procrit | 351(a) | Rx | Amgen, Inc. |
| 2020-10-01 | U | 004 | Epogen/Procrit | 351(a) | Rx | Amgen, Inc. |
| 2020-10-01 | U | 005 | Epogen/Procrit | 351(a) | Rx | Amgen, Inc. |
| 2020-10-01 | U | 006 | Procrit | 351(a) | Rx | Amgen, Inc. |
| 2020-10-01 | U | 007 | Epogen/Procrit | 351(a) | Rx | Amgen, Inc. |
| 2020-08-01 | U | 001 | Epogen/Procrit | 351(a) | Rx | Amgen Inc. |
| 2020-08-01 | U | 002 | Epogen/Procrit | 351(a) | Rx | Amgen Inc. |
| 2020-08-01 | U | 003 | Epogen/Procrit | 351(a) | Rx | Amgen Inc. |
| 2020-08-01 | U | 004 | Epogen/Procrit | 351(a) | Rx | Amgen Inc. |
| 2020-08-01 | U | 005 | Epogen/Procrit | 351(a) | Rx | Amgen Inc. |
| 2020-08-01 | U | 006 | Procrit | 351(a) | Rx | Amgen Inc. |
| 2020-08-01 | U | 007 | Epogen/Procrit | 351(a) | Rx | Amgen Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2020-06-01 | 006 | Procrit | 351(a) | Rx | Licensed | |
| 2020-05-01 | 001 | Epogen/Procrit | 351(a) | Rx | Licensed | 1989-06-01 |
| 2020-05-01 | 002 | Epogen/Procrit | 351(a) | Rx | Licensed | |
| 2020-05-01 | 003 | Epogen/Procrit | 351(a) | Rx | Licensed | |
| 2020-05-01 | 004 | Epogen/Procrit | 351(a) | Rx | Licensed | 1989-06-01 |
| 2020-05-01 | 005 | Epogen/Procrit | 351(a) | Rx | Licensed | 1989-06-01 |
| 2020-05-01 | 006 | Epogen/Procrit | 351(a) | Rx | Licensed | |
| 2020-05-01 | 007 | Epogen/Procrit | 351(a) | Rx | Licensed | 1989-06-01 |
| 2020-02-01 | 001 | Procrit | 351(a) | Marketed | Licensed | 1989-06-01 |
| 2020-02-01 | 002 | Procrit | 351(a) | Marketed | Licensed | |
| 2020-02-01 | 003 | Procrit | 351(a) | Marketed | Licensed | |
| 2020-02-01 | 004 | Procrit | 351(a) | Marketed | Licensed | 1989-06-01 |
| 2020-02-01 | 005 | Procrit | 351(a) | Marketed | Licensed | 1989-06-01 |
| 2020-02-01 | 006 | Procrit | 351(a) | Marketed | Licensed | |
| 2020-02-01 | 007 | Procrit | 351(a) | Marketed | Licensed | 1989-06-01 |