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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
BLA Number
021081
Applicant
Sanofi-Aventis U.S. LLC
Original Approval Date
April 20, 2000
Date of First Licensure