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Purple Book
Database of Licensed Biological Products

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

Product NumberDosage FormRoute of AdministrationStrengthProduct PresentationLicense TypeProprietary NameMarketing Status
001Injection Subcutaneous1,000UNITS/10ML (100 UNITS/ML)Multi-Dose Vial351(a)SemgleeDisc
002Injection Subcutaneous300UNITS/3ML (100UNITS/ML)Autoinjector351(a)SemgleeDisc

Proper Name
insulin glargine

BLA Number
210605

Applicant
Mylan Pharmaceuticals Inc.

Original Approval Date
June 11, 2020

Date of First Licensure