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Generated: November 12, 2018

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Details for New Drug Application (NDA): 020744

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NDA 020744 describes CUROSURF, which is a drug marketed by Chiesi Usa Inc and is included in one NDA. It is available from one supplier. Additional details are available on the CUROSURF profile page.

The generic ingredient in CUROSURF is poractant alfa. One supplier is listed for this compound. Additional details are available on the poractant alfa profile page.
Summary for 020744
Tradename:CUROSURF
Applicant:Chiesi Usa Inc
Ingredient:poractant alfa
Patents:0
Pharmacology for NDA: 020744
Mechanism of ActionSurfactant Activity
Physiological EffectAlveolar Surface Tension Reduction
Suppliers and Packaging for NDA: 020744
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CUROSURF poractant alfa SUSPENSION;INTRATRACHEAL 020744 NDA Chiesi USA, Inc. 10122-510 10122-510-01 1.5 mL in 1 VIAL, GLASS (10122-510-01)
CUROSURF poractant alfa SUSPENSION;INTRATRACHEAL 020744 NDA Chiesi USA, Inc. 10122-510 10122-510-03 3 mL in 1 VIAL, GLASS (10122-510-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;INTRATRACHEALStrength80MG/ML
Approval Date:Nov 18, 1999TE:RLD:Yes

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