Product Details for: Winrevair
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Subcutaneous
45MG
Single-Dose Vial
351(a)
Winrevair
Rx
002
For Injection
Subcutaneous
60MG
Single-Dose Vial
351(a)
Winrevair
Rx
Proper Name
sotatercept-csrk
sotatercept-csrk
BLA Number
761363
761363
Applicant
Merck Sharp & Dohme LLC
Merck Sharp & Dohme LLC
Original Approval Date
March 26, 2024
March 26, 2024
Date of First Licensure