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 (100 UNITS/ML)
Multi-Dose Vial
351(a)
Semglee
Disc
002
Injection
Subcutaneous
300UNITS/3ML (100UNITS/ML)
Autoinjector
351(a)
Semglee
Disc
Proper Name
insulin glargine
BLA Number
210605
Applicant
Mylan Pharmaceuticals Inc.
Original Approval Date
June 11, 2020
Date of First Licensure
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