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Humalog Mix 50/50
insulin lispro protamine and insulin lispro
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Humalog Mix 50/50
Proper name
insulin lispro protamine and insulin lispro
Licence type
351(a)
BLA number
021018
Applicant
Eli Lilly and Company
Center
CDER
Presentations
3
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 150UNITS/3ML (50UNITS/ML); 150UNITS/3ML (50UNITS/ML) | Injectable Suspension | Subcutaneous | Autoinjector | Rx | September 6, 2007 |
| 150UNITS/3ML (50UNITS/ML); 150UNITS/3ML (50UNITS/ML) | Injectable Suspension | Subcutaneous | Autoinjector | Disc | December 22, 1999 |
| 500UNITS/10ML (50UNITS/ML); 500UNITS/10ML (50UNITS/ML) | Injectable Suspension | Subcutaneous | Multi-Dose Vial | Disc | December 22, 1999 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |