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Humulin R U-100
insulin human
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Humulin R U-100
Proper name
insulin human
Licence type
351(a)
BLA number
018780
Applicant
Eli Lilly and Company
Center
CDER
Presentations
3
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1,000UNITS/10ML (100UNITS/ML) | Injection | Subcutaneous | Multi-Dose Vial | OTC | October 28, 1982 |
| 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Autoinjector | Disc | August 6, 1998 |
| 300UNITS/3ML (100UNITS/ML) | Injection | Subcutaneous | Multi-Dose Vial | OTC | May 25, 2018 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |