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Humalog
insulin lispro
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Humalog
Proper name
insulin lispro
Licence type
351(a)
BLA number
020563
Applicant
Eli Lilly and Company
Center
CDER
Presentations
8
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1,000UNITS/10ML (100UNITS/ML) | Injection | Intravenous, Subcutaneous | Multi-Dose Vial | Rx | June 14, 1996 |
| 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Multi-Dose Cartridge | Disc | August 6, 1998 |
| 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | September 6, 2007 |
| 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | June 6, 2017 |
| 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | November 15, 2019 |
| 300UNITS/3ML (100UNITS/ML) | Injection | Intravenous, Subcutaneous | Multi-Dose Vial | Rx | June 14, 1996 |
| 600UNITS/3ML (200UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | May 26, 2015 |
| 600UNITS/3ML (200UNITS/ML) | Injection | Subcutaneous | Autoinjector | Rx | May 7, 2025 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |