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Purple Book
Database of Licensed Biological Products

Product Details for: Lantus
Product Label Grayed out Product Label links indicate that there is no product label available for the product.

Product NumberDosage FormRoute of AdministrationStrengthProduct PresentationLicense TypeProprietary NameMarketing Status
001Injection Subcutaneous1,000UNITS/10ML (100UNITS/ML)Multi-Dose Vial351(a)LantusRx
002Injection Subcutaneous300UNITS/3ML (100UNITS/ML)Autoinjector351(a)LantusRx
003Injection Subcutaneous500UNITS/5ML (100UNITS/ML)Multi-Dose Vial351(a)LantusDisc
004Injection Subcutaneous300UNITS/3ML (100UNITS/ML)Multi-Dose Cartridge351(a)LantusDisc

Proper Name
insulin glargine

BLA Number
021081

Applicant
Sanofi-Aventis U.S. LLC

Original Approval Date
April 20, 2000

Date of First Licensure