GENOSYL
These highlights do not include all the information needed to use GENOSYL safely and effectively. See full prescribing information for GENOSYL.GENOSYL (nitric oxide), for inhalation use Initial U.S. Approval: 1999
Approved
Approval ID
c9560c54-9e28-4039-a4e5-5000c41c6c85
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 19, 2023
Manufacturers
FDA
VERO BIOTECH, INC.
DUNS: 872672477
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
nitric oxide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72385-001
Application NumberNDA202860
Product Classification
M
Marketing Category
C73594
G
Generic Name
nitric oxide
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateDecember 19, 2023
FDA Product Classification
INGREDIENTS (1)
NITRIC OXIDEActive
Quantity: 0.98 mg in 1 L
Code: 31C4KY9ESH
Classification: ACTIB