Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
ONY Biotech Inc.
622369833
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
ONY Biotech Inc.
ONY Biotech Inc.
ONY Biotech Inc.
622369833
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
INFASURF
Product Details
NDC Product Code
61938-456Application Number
BLA020521Marketing Category
BLA (C73585)Route of Administration
ENDOTRACHEALEffective Date
September 26, 2023SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
CalfactantActive
Code: Q4K217VGA9Class: ACTIBQuantity: 35.7 mg in 1 mL