MedPath
FDA Approval

Helium Oxygen Mix

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Airgas-West, Inc.
DUNS: 805645793
Effective Date
April 30, 2010
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Helium(600 mL in 1 L)
Oxygen(400 mL in 1 L)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Airgas-West, Inc.

Airgas-West, Inc.

959935354

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Helium Oxygen Mix

Product Details

NDC Product Code
10678-007
Route of Administration
RESPIRATORY (INHALATION)
Effective Date
April 30, 2010
HeliumActive
Code: 206GF3GB41Class: ACTIBQuantity: 600 mL in 1 L
OxygenActive
Code: S88TT14065Class: ACTIBQuantity: 400 mL in 1 L
© Copyright 2025. All Rights Reserved by MedPath