Product Details for: Semglee Product Label Grayed out Product Label links indicate that there is no product label available for the product.
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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