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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(k) Interchangeable | Semglee | Rx |
002 | Injection | Subcutaneous | 300UNITS/3ML (100UNITS/ML) | Autoinjector | 351(k) Interchangeable | Semglee | Rx |
Proper Name
insulin glargine-yfgn
Reference Product Proper Name
insulin glargine
Reference Product Proprietary Name
Lantus
BLA Number
761201
Applicant
Biocon Biologics Inc.
Original Approval Date
July 28, 2021
Date of First Licensure