Novolog Purple Book BLA 020986
- BLA number
- 020986
- Proprietary names
- Novolog
- Proper names
- insulin aspart
- 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 | Novolog | insulin aspart | 351(a) | 1,000UNITS/10ML (100UNITS/ML) | Injection | Intravenous, Subcutaneous | Multi-Dose Vial | Rx | Licensed | 2000-06-07 | |
| 002 | Novolog | insulin aspart | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Multi-Dose Cartridge | Rx | Licensed | 2000-06-07 | |
| 003 | Novolog | insulin aspart | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | Licensed | 2001-01-19 | |
| 004 | Novolog | insulin aspart | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Disc | Licensed | 2004-04-23 | |
| 005 | Novolog | insulin aspart | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Disc | Licensed | 2013-10-31 | |
Biosimilar And Interchangeable Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761188 | Kirsty | insulin aspart-xjhz | 351(k) Interchangeable | Rx | 2026-06-01 |
| 761325 | Merilog | insulin aspart-szjj | 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 |
|---|
| 2023-07-01 | U | 005 | Novolog | 351(a) | Disc | Novo Nordisk Inc. |
| 2023-03-01 | U | 005 | Novolog | 351(a) | Rx | Novo Nordisk Inc. |
| 2020-05-01 | R | 001 | Novolog | 351(a) | Rx | Novo Nordisk Inc. |
| 2020-05-01 | R | 002 | Novolog | 351(a) | Rx | Novo Nordisk Inc. |
| 2020-05-01 | R | 003 | Novolog | 351(a) | Rx | Novo Nordisk Inc. |
| 2020-05-01 | R | 004 | Novolog | 351(a) | Disc | Novo Nordisk Inc. |
| 2020-05-01 | R | 005 | Novolog | 351(a) | Disc | Novo Nordisk Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2023-07-01 | 005 | Novolog | 351(a) | Disc | Licensed | 2013-10-31 |
| 2023-03-01 | 005 | Novolog | 351(a) | Rx | Licensed | 2013-10-31 |
| 2020-05-01 | 001 | Novolog | 351(a) | Rx | Licensed | 2000-06-07 |
| 2020-05-01 | 002 | Novolog | 351(a) | Rx | Licensed | 2000-06-07 |
| 2020-05-01 | 003 | Novolog | 351(a) | Rx | Licensed | 2001-01-19 |
| 2020-05-01 | 004 | Novolog | 351(a) | Disc | Licensed | 2004-04-23 |
| 2020-05-01 | 005 | Novolog | 351(a) | Disc | Licensed | 2013-10-31 |