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FDA Approval

Oxygen

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

FDA Approval Summary

Company
Effective Date
July 19, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Oxygen(990 mL in 1 L)

Manufacturing Establishments1

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

AMERICAN GASES CORPORATION

AMERICAN GASES CORPORATION

796515054

Products1

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

Oxygen

Product Details

NDC Product Code
82606-001
Application Number
NDA205767
Marketing Category
NDA (C73594)
Route of Administration
RESPIRATORY (INHALATION)
Effective Date
July 19, 2022
OxygenActive
Code: S88TT14065Class: ACTIBQuantity: 990 mL in 1 L
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