Product Details for: Besremi
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
500MCG/ML
Pre-Filled Syringe
351(a)
Besremi
Rx
Proper Name
ropeginterferon alfa-2b-njft
ropeginterferon alfa-2b-njft
BLA Number
761166
761166
Applicant
PharmaEssentia Corporation
PharmaEssentia Corporation
Original Approval Date
November 12, 2021
November 12, 2021
Date of First Licensure