Zomacton Purple Book BLA 019774
- BLA number
- 019774
- Proprietary names
- Zomacton
- Proper names
- somatropin
- Applicant
- Ferring Pharmaceuticals 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 | Zomacton | somatropin | 351(a) | 4.8MG | For Injection | Subcutaneous | Multi-Dose Vial | Disc | Licensed | 1995-05-25 | |
| 002 | Zomacton | somatropin | 351(a) | 5MG | For Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | 2002-01-04 | |
| 003 | Zomacton | somatropin | 351(a) | 10MG | For Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | 2012-03-07 | |
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 |
|---|
| 2023-06-01 | U | 001 | Zomacton | 351(a) | Disc | Ferring Pharmaceuticals Inc. |
| 2020-05-01 | R | 001 | Zomacton | 351(a) | Rx | Ferring Pharmaceuticals Inc. |
| 2020-05-01 | R | 002 | Zomacton | 351(a) | Rx | Ferring Pharmaceuticals Inc. |
| 2020-05-01 | R | 003 | Zomacton | 351(a) | Rx | Ferring Pharmaceuticals Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2023-06-01 | 001 | Zomacton | 351(a) | Disc | Licensed | 1995-05-25 |
| 2020-05-01 | 001 | Zomacton | 351(a) | Rx | Licensed | 1995-05-25 |
| 2020-05-01 | 002 | Zomacton | 351(a) | Rx | Licensed | 2002-01-04 |
| 2020-05-01 | 003 | Zomacton | 351(a) | Rx | Licensed | 2012-03-07 |