Norditropin Purple Book BLA 021148
- BLA number
- 021148
- Proprietary names
- Norditropin
- Proper names
- somatropin
- Applicant
- Novo Nordisk 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 | Norditropin | somatropin | 351(a) | 5MG/1.5ML | Injection | Subcutaneous | Multi-Dose Cartridge | Disc | Licensed | 2000-06-20 | |
| 002 | Norditropin | somatropin | 351(a) | 10MG/1.5ML | Injection | Subcutaneous | Multi-Dose Cartridge | Disc | Licensed | 2000-06-20 | |
| 003 | Norditropin | somatropin | 351(a) | 15MG/1.5ML | Injection | Subcutaneous | Multi-Dose Cartridge | Disc | Licensed | 2000-06-20 | |
| 004 | Norditropin | somatropin | 351(a) | 5MG/1.5ML | Injection | Subcutaneous | Autoinjector | Disc | Licensed | 2004-10-01 | |
| 005 | Norditropin | somatropin | 351(a) | 10MG/1.5ML | Injection | Subcutaneous | Autoinjector | Disc | Licensed | 2004-10-01 | |
| 006 | Norditropin | somatropin | 351(a) | 15MG/1.5ML | Injection | Subcutaneous | Autoinjector | Disc | Licensed | 2004-10-01 | |
| 007 | Norditropin | somatropin | 351(a) | 30MG/3ML | Injection | Subcutaneous | Autoinjector | Disc | Licensed | 2009-03-10 | |
| 008 | Norditropin | somatropin | 351(a) | 5MG/1.5ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2010-03-01 | |
| 009 | Norditropin | somatropin | 351(a) | 10MG/1.5ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2010-03-01 | |
| 010 | Norditropin | somatropin | 351(a) | 15MG/1.5ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2010-03-01 | |
| 011 | Norditropin | somatropin | 351(a) | 30MG/3ML | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2015-01-23 | |
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 | Norditropin | 351(a) | Disc | Novo Nordisk Inc. |
| 2021-04-01 | U | 002 | Norditropin | 351(a) | Disc | Novo Nordisk Inc. |
| 2021-04-01 | U | 003 | Norditropin | 351(a) | Disc | Novo Nordisk Inc. |
| 2021-04-01 | U | 007 | Norditropin | 351(a) | Disc | Novo Nordisk Inc. |
| 2021-04-01 | U | 008 | Norditropin | 351(a) | Rx | Novo Nordisk Inc. |
| 2021-04-01 | U | 009 | Norditropin | 351(a) | Rx | Novo Nordisk Inc. |
| 2021-04-01 | U | 010 | Norditropin | 351(a) | Rx | Novo Nordisk Inc. |
| 2021-04-01 | U | 011 | Norditropin | 351(a) | Rx | Novo Nordisk Inc. |
| 2020-08-01 | U | 001 | Norditropin | 351(a) | Disc | Novo Nordisk Inc. |
| 2020-08-01 | U | 002 | Norditropin | 351(a) | Disc | Novo Nordisk Inc. |
| 2020-08-01 | U | 003 | Norditropin | 351(a) | Disc | Novo Nordisk Inc. |
| 2020-08-01 | U | 004 | Norditropin | 351(a) | Disc | Novo Nordisk Inc. |
| 2020-08-01 | U | 005 | Norditropin | 351(a) | Disc | Novo Nordisk Inc. |
| 2020-08-01 | U | 006 | Norditropin | 351(a) | Disc | Novo Nordisk Inc. |
| 2020-08-01 | U | 007 | Norditropin | 351(a) | Disc | Novo Nordisk Inc. |
| 2020-08-01 | U | 008 | Norditropin | 351(a) | Rx | Novo Nordisk Inc. |
| 2020-08-01 | U | 009 | Norditropin | 351(a) | Rx | Novo Nordisk Inc. |
| 2020-08-01 | U | 010 | Norditropin | 351(a) | Rx | Novo Nordisk Inc. |
| 2020-08-01 | U | 011 | Norditropin | 351(a) | Rx | Novo Nordisk Inc. |
| 2020-05-01 | R | 001 | Norditropin | 351(a) | Disc | Novo Nordisk Inc. |
| 2020-05-01 | R | 002 | Norditropin | 351(a) | Disc | Novo Nordisk Inc. |
| 2020-05-01 | R | 003 | Norditropin | 351(a) | Disc | Novo Nordisk Inc. |
| 2020-05-01 | R | 004 | Norditropin | 351(a) | Disc | Novo Nordisk Inc. |
| 2020-05-01 | R | 005 | Norditropin | 351(a) | Disc | Novo Nordisk Inc. |
| 2020-05-01 | R | 006 | Norditropin | 351(a) | Disc | Novo Nordisk Inc. |
| 2020-05-01 | R | 007 | Norditropin | 351(a) | Disc | Novo Nordisk Inc. |
| 2020-05-01 | R | 008 | Norditropin | 351(a) | Rx | Novo Nordisk Inc. |
| 2020-05-01 | R | 009 | Norditropin | 351(a) | Rx | Novo Nordisk Inc. |
| 2020-05-01 | R | 010 | Norditropin | 351(a) | Rx | Novo Nordisk Inc. |
| 2020-05-01 | R | 011 | Norditropin | 351(a) | Rx | Novo Nordisk Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2020-05-01 | 001 | Norditropin | 351(a) | Disc | Licensed | 2000-06-20 |
| 2020-05-01 | 002 | Norditropin | 351(a) | Disc | Licensed | 2000-06-20 |
| 2020-05-01 | 003 | Norditropin | 351(a) | Disc | Licensed | 2000-06-20 |
| 2020-05-01 | 004 | Norditropin | 351(a) | Disc | Licensed | 2004-10-01 |
| 2020-05-01 | 005 | Norditropin | 351(a) | Disc | Licensed | 2004-10-01 |
| 2020-05-01 | 006 | Norditropin | 351(a) | Disc | Licensed | 2004-10-01 |
| 2020-05-01 | 007 | Norditropin | 351(a) | Disc | Licensed | 2009-03-10 |
| 2020-05-01 | 008 | Norditropin | 351(a) | Rx | Licensed | 2010-03-01 |
| 2020-05-01 | 009 | Norditropin | 351(a) | Rx | Licensed | 2010-03-01 |
| 2020-05-01 | 010 | Norditropin | 351(a) | Rx | Licensed | 2010-03-01 |
| 2020-05-01 | 011 | Norditropin | 351(a) | Rx | Licensed | 2015-01-23 |