Product Details for: Omlyclo

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
75MG/0.5ML
Pre-Filled Syringe
351(k) Interchangeable
Omlyclo
Rx
002
Injection
Subcutaneous
150MG/ML
Pre-Filled Syringe
351(k) Interchangeable
Omlyclo
Rx
003
Injection
Subcutaneous
300MG/2ML (150MG/ML)
Pre-Filled Syringe
351(k) Interchangeable
Omlyclo
Rx
Proper Name
omalizumab-igec
Reference Product Proper Name
omalizumab
Reference Product Properietary Name
Xolair
BLA Number
761399
Applicant
CELLTRION, Inc.
Original Approval Date
March 7, 2025
Date of First Licensure
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