Product Details for: Curosurf
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Suspension
Intratracheal
120MG/1.5ML (80MG/ML)
Single-Dose Vial
351(a)
Curosurf
Rx
002
Suspension
Intratracheal
240MG/3ML (80MG/ML)
Single-Dose Vial
351(a)
Curosurf
Rx
Proper Name
poractant alfa
poractant alfa
BLA Number
020744
020744
Applicant
Chiesi USA, Inc.
Chiesi USA, Inc.
Original Approval Date
November 18, 1999
November 18, 1999
Date of First Licensure