Product Details for: Alymsys

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
100MG/4ML (25MG/ML)
Single-Dose Vial
351(k) Biosimilar
Alymsys
Rx
002
Injection
Intravenous
400MG/16ML (25MG/ML)
Single-Dose Vial
351(k) Biosimilar
Alymsys
Rx
Proper Name
bevacizumab-maly
Reference Product Proper Name
bevacizumab
Reference Product Properietary Name
Avastin
BLA Number
761231
Applicant
Amneal Pharmaceuticals LLC
Original Approval Date
April 13, 2022
Date of First Licensure
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