Product Details for: Trazimera

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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
Trazimera
Rx
002
For Injection
Intravenous
150MG
Multi-Dose Vial
351(k) Biosimilar
Trazimera
Rx
Proper Name
trastuzumab-qyyp
Reference Product Proper Name
trastuzumab
Reference Product Properietary Name
Herceptin
BLA Number
761081
Applicant
Pfizer Ireland Pharmaceuticals Unlimited Company
Original Approval Date
March 11, 2019
Date of First Licensure
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