Omnitrope Purple Book BLA 021426
- BLA number
- 021426
- Proprietary names
- Omnitrope
- Proper names
- somatropin
- Applicant
- Sandoz 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 | Omnitrope | somatropin | 351(a) | 5.8MG | For Injection | Subcutaneous | Multi-Dose Vial | Rx | Licensed | 2006-05-30 | |
| 002 | Omnitrope | somatropin | 351(a) | 1.5MG | For Injection | Subcutaneous | Single-Dose Vial | Disc | Licensed | 2006-05-30 | |
| 003 | Omnitrope | somatropin | 351(a) | 5MG/1.5ML | Injection | Subcutaneous | Multi-Dose Cartridge | Rx | Licensed | 2008-01-16 | |
| 004 | Omnitrope | somatropin | 351(a) | 10MG/1.5ML | Injection | Subcutaneous | Multi-Dose Cartridge | Rx | Licensed | 2008-08-25 | |
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 |
|---|
| 2021-04-01 | U | 001 | Omnitrope | 351(a) | Rx | Sandoz Inc. |
| 2021-04-01 | U | 002 | Omnitrope | 351(a) | Disc | Sandoz Inc. |
| 2021-04-01 | U | 003 | Omnitrope | 351(a) | Rx | Sandoz Inc. |
| 2021-04-01 | U | 004 | Omnitrope | 351(a) | Rx | Sandoz Inc. |
| 2020-05-01 | R | 001 | Omnitrope | 351(a) | Rx | Sandoz Inc. |
| 2020-05-01 | R | 002 | Omnitrope | 351(a) | Disc | Sandoz Inc. |
| 2020-05-01 | R | 003 | Omnitrope | 351(a) | Rx | Sandoz Inc. |
| 2020-05-01 | R | 004 | Omnitrope | 351(a) | Rx | Sandoz Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2020-05-01 | 001 | Omnitrope | 351(a) | Rx | Licensed | 2006-05-30 |
| 2020-05-01 | 002 | Omnitrope | 351(a) | Disc | Licensed | 2006-05-30 |
| 2020-05-01 | 003 | Omnitrope | 351(a) | Rx | Licensed | 2008-01-16 |
| 2020-05-01 | 004 | Omnitrope | 351(a) | Rx | Licensed | 2008-08-25 |