Product Details for: Kanjinti
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
420MG
Multi-Dose Vial
351(k) Biosimilar
Kanjinti
Rx
002
For Injection
Intravenous
150MG
Single-Dose Vial
351(k) Biosimilar
Kanjinti
Rx
Proper Name
trastuzumab-anns
trastuzumab-anns
Reference Product Proper Name
trastuzumab
trastuzumab
Reference Product Properietary Name
Herceptin
Herceptin
BLA Number
761073
761073
Applicant
Amgen Inc.
Amgen Inc.
Original Approval Date
June 13, 2019
June 13, 2019
Date of First Licensure