Product Details for: Libtayo
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
350MG/7ML (50MG/ML)
Single-Dose Vial
351(a)
Libtayo
Rx
Proper Name
cemiplimab-rwlc
cemiplimab-rwlc
BLA Number
761097
761097
Applicant
Regeneron Pharmaceuticals, Inc.
Regeneron Pharmaceuticals, Inc.
Original Approval Date
September 28, 2018
September 28, 2018
Date of First Licensure