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FDA Approval

Helium

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

FDA Approval Summary

Effective Date
June 14, 2010
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Helium(999 mL in 1 L)

Manufacturing Establishments1

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

Airgas Northern California and Nevada, Inc.

Airgas Northern California and Nevada, Inc.

946304797

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
58789-005
Route of Administration
RESPIRATORY (INHALATION)
Effective Date
May 20, 2010
HeliumActive
Code: 206GF3GB41Class: ACTIBQuantity: 999 mL in 1 L
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