Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Machine & Welding Supply Company dba Arc3 Gases South
Machine & Welding Supply Company dba Arc3 Gases South
065300535
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Helium
Product Details
NDC Product Code
49575-020Application Number
NDA205851Marketing Category
NDA (C73594)Route of Administration
RESPIRATORY (INHALATION)Effective Date
December 8, 2023HeliumActive
Code: 206GF3GB41Class: ACTIBQuantity: 990 mL in 1 L