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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 (100UNITS/ML)Multi-Dose Vial351(k) InterchangeableSemgleeRx
002Injection Subcutaneous300UNITS/3ML (100UNITS/ML)Autoinjector351(k) InterchangeableSemgleeRx

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