Product Details for: Mylotarg

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
4.5MG
Single-Dose Vial
351(a)
Mylotarg
Rx
Proper Name
gemtuzumab ozogamicin
BLA Number
761060
Applicant
Wyeth Pharmaceuticals LLC
Original Approval Date
September 1, 2017
Date of First Licensure
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