Semglee Purple Book BLA 210605
- BLA number
- 210605
- Proprietary names
- Semglee
- Proper names
- insulin glargine
- Applicant
- Mylan Pharmaceuticals Inc.
- Center
- CDER
- First observed release
- 2020-06-01
- 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 | Semglee | insulin glargine | 351(a) | 1,000UNITS/10ML (100 UNITS/ML) | Injection | Subcutaneous | Multi-Dose Vial | Disc | Voluntarily Revoked | 2020-06-11 | |
| 002 | Semglee | insulin glargine | 351(a) | 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Disc | Voluntarily Revoked | 2020-06-11 | |
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 |
|---|
| 2022-10-01 | U | 001 | Semglee | 351(a) | Disc | Mylan Pharmaceuticals Inc. |
| 2022-10-01 | U | 002 | Semglee | 351(a) | Disc | Mylan Pharmaceuticals Inc. |
| 2020-06-01 | N | 001 | Semglee | 351(a) | Rx | Mylan Pharmaceuticals Inc. |
| 2020-06-01 | N | 002 | Semglee | 351(a) | Rx | Mylan Pharmaceuticals Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2022-10-01 | 001 | Semglee | 351(a) | Disc | Voluntarily Revoked | 2020-06-11 |
| 2022-10-01 | 002 | Semglee | 351(a) | Disc | Voluntarily Revoked | 2020-06-11 |
| 2020-06-01 | 001 | Semglee | 351(a) | Rx | Licensed | 2020-06-11 |
| 2020-06-01 | 002 | Semglee | 351(a) | Rx | Licensed | 2020-06-11 |