Product Details for: Semglee

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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 Properietary Name
Lantus
BLA Number
761201
Applicant
Biocon Biologics Inc.
Original Approval Date
July 28, 2021
Date of First Licensure
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