Product Details for: Lantus
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
1,000UNITS/10ML (100UNITS/ML)
Multi-Dose Vial
351(a)
Lantus
Rx
002
Injection
Subcutaneous
300UNITS/3ML (100UNITS/ML)
Autoinjector
351(a)
Lantus
Rx
003
Injection
Subcutaneous
500UNITS/5ML (100UNITS/ML)
Multi-Dose Vial
351(a)
Lantus
Disc
004
Injection
Subcutaneous
300UNITS/3ML (100UNITS/ML)
Multi-Dose Cartridge
351(a)
Lantus
Disc
Proper Name
insulin glargine
insulin glargine
BLA Number
021081
021081
Applicant
Sanofi-Aventis U.S. LLC
Sanofi-Aventis U.S. LLC
Original Approval Date
April 20, 2000
April 20, 2000
Date of First Licensure