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Humulin 70/30
insulin isophane human and insulin human
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Humulin 70/30
Proper name
insulin isophane human and insulin human
Licence type
351(a)
BLA number
019717
Applicant
Eli Lilly and Company
Center
CDER
Presentations
3
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 210UNITS/3ML (70UNITS/ML); 90UNITS/3ML (30UNITS/ML) | Injectable Suspension | Subcutaneous | Multi-Dose Vial | OTC | April 25, 1989 |
| 210UNITS/3ML (70UNITS/ML); 90UNITS/3ML (30UNITS/ML) | Injectable Suspension | Subcutaneous | Autoinjector | OTC | November 7, 2013 |
| 700UNITS/10ML (70UNITS/ML); 300UNITS/10ML (30UNITS/ML) | Injectable Suspension | Subcutaneous | Multi-Dose Vial | OTC | April 25, 1989 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |