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Generated: January 23, 2019

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Details for New Drug Application (NDA): 020521

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NDA 020521 describes INFASURF PRESERVATIVE FREE, which is a drug marketed by ONY and is included in one NDA. It is available from one supplier. Additional details are available on the INFASURF PRESERVATIVE FREE profile page.

The generic ingredient in INFASURF PRESERVATIVE FREE is calfactant. One supplier is listed for this compound. Additional details are available on the calfactant profile page.
Summary for 020521
Tradename:INFASURF PRESERVATIVE FREE
Applicant:Ony
Ingredient:calfactant
Patents:0
Pharmacology for NDA: 020521
Mechanism of ActionSurfactant Activity
Physiological EffectAlveolar Surface Tension Reduction
Suppliers and Packaging for NDA: 020521
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INFASURF PRESERVATIVE FREE calfactant SUSPENSION;INTRATRACHEAL 020521 NDA Ony, Inc. 61938-456 61938-456-03 1 VIAL, GLASS in 1 CARTON (61938-456-03) > 3 mL in 1 VIAL, GLASS
INFASURF PRESERVATIVE FREE calfactant SUSPENSION;INTRATRACHEAL 020521 NDA Ony, Inc. 61938-456 61938-456-06 1 VIAL, GLASS in 1 CARTON (61938-456-06) > 6 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;INTRATRACHEALStrength35MG/ML
Approval Date:Jul 1, 1998TE:RLD:Yes

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