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Lantus

insulin glargine

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Lantus
Proper name
insulin glargine
Licence type
351(a)
BLA number
021081
Applicant
Sanofi-Aventis U.S. LLC
Center
CDER
Presentations
4
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 Subcutaneous Multi-Dose Vial Rx April 20, 2000
300UNITS/3ML (100UNITS/ML) Injection Subcutaneous Autoinjector Rx April 25, 2007
300UNITS/3ML (100UNITS/ML) Injection Subcutaneous Multi-Dose Cartridge Disc April 20, 2000
500UNITS/5ML (100UNITS/ML) Injection Subcutaneous Multi-Dose Vial Disc April 20, 2000

Sources for this page

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