INFASURF
INFASURF Intratracheal Suspension Sterile Suspension for Intratracheal Use Only Rx only Rev.03/18
Approved
Approval ID
315c128a-272d-4c57-bfbe-1a8b3402af08
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 26, 2023
Manufacturers
FDA
ONY Biotech Inc.
DUNS: 622369833
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CALFACTANT
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61938-456
Application NumberBLA020521
Product Classification
M
Marketing Category
C73585
G
Generic Name
CALFACTANT
Product Specifications
Route of AdministrationENDOTRACHEAL
Effective DateSeptember 26, 2023
FDA Product Classification
INGREDIENTS (2)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
CALFACTANTActive
Quantity: 35.7 mg in 1 mL
Code: Q4K217VGA9
Classification: ACTIB