Novolog Mix 50/50 Purple Book BLA 021810
- BLA number
- 021810
- Proprietary names
- Novolog Mix 50/50
- Proper names
- insulin aspart protamine and 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 Mix 50/50 | insulin aspart protamine and insulin aspart | 351(a) | 150UNITS/3ML (50UNITS/ML); 150UNITS/3ML (50UNITS/ML) | Injectable Suspension | Subcutaneous | Multi-Dose Cartridge | Disc | Voluntarily Revoked | 2008-08-26 | |
| 002 | Novolog Mix 50/50 | insulin aspart protamine and insulin aspart | 351(a) | 150UNITS/3ML (50UNITS/ML); 150UNITS/3ML (50UNITS/ML) | Injectable Suspension | Subcutaneous | Autoinjector | Disc | Voluntarily Revoked | 2008-08-26 | |
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 |
|---|
| 2022-08-01 | U | 001 | Novolog Mix 50/50 | 351(a) | Disc | Novo Nordisk Inc. |
| 2022-08-01 | U | 002 | Novolog Mix 50/50 | 351(a) | Disc | Novo Nordisk Inc. |
| 2021-08-01 | U | 002 | Novolog Mix 50/50 | 351(a) | Disc | Novo Nordisk Inc. |
| 2020-05-01 | R | 001 | Novolog Mix 50/50 | 351(a) | Disc | Novo Nordisk Inc. |
| 2020-05-01 | R | 002 | Novolog Mix 50/50 | 351(a) | Disc | Novo Nordisk Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2022-08-01 | 001 | Novolog Mix 50/50 | 351(a) | Disc | Voluntarily Revoked | 2008-08-26 |
| 2022-08-01 | 002 | Novolog Mix 50/50 | 351(a) | Disc | Voluntarily Revoked | 2008-08-26 |
| 2020-05-01 | 001 | Novolog Mix 50/50 | 351(a) | Disc | Licensed | 2008-08-26 |
| 2020-05-01 | 002 | Novolog Mix 50/50 | 351(a) | Disc | Licensed | 2008-08-26 |