OpenRx Open Medications Explorer
© 2026 OpenRx · public-domain U.S. government data
On this page

Admelog

insulin lispro

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Admelog
Proper name
insulin lispro
Licence type
351(a)
BLA number
209196
Applicant
Sanofi-Aventis U.S. LLC
Center
CDER
Presentations
3
First licensure
—

Presentations

Source: Purple Book
Every strength and presentation recorded in the Purple Book for this product.
Strength Dosage form Route Presentation Status Licensed
1,000UNITS/10ML (100UNITS/ML) Injection Intravenous, Subcutaneous Multi-Dose Vial Rx December 11, 2017
300UNITS/3ML (100UNITS/ML) Injection Subcutaneous Autoinjector Rx December 11, 2017
300UNITS/3ML (100UNITS/ML) Injection Intravenous, Subcutaneous Multi-Dose Vial Rx October 19, 2018

Sources for this page

Purple Book FDA Licence type, presentations, reference product, exclusivity