Product Details for: Ontruzant

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
150MG
Single-Dose Vial
351(k) Biosimilar
Ontruzant
Rx
002
For Injection
Intravenous
420MG
Multi-Dose Vial
351(k) Biosimilar
Ontruzant
Rx
Proper Name
trastuzumab-dttb
Reference Product Proper Name
trastuzumab
Reference Product Properietary Name
Herceptin
BLA Number
761100
Applicant
Samsung Bioepis Co., Ltd.
Original Approval Date
January 18, 2019
Date of First Licensure
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