Product Details for: Myalept
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Subcutaneous
11.3MG
Single-Dose Vial
351(a)
Myalept
Rx
Proper Name
metreleptin
metreleptin
BLA Number
125390
125390
Applicant
Chiesi Farmaceutici S.p.A.
Chiesi Farmaceutici S.p.A.
Original Approval Date
February 24, 2014
February 24, 2014
Date of First Licensure