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FDA Approval

Oxygen

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

FDA Approval Summary

Effective Date
December 27, 2017
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Oxygen(210 mL in 1 L)

Manufacturing Establishments1

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

CENTRAL NEBRASKA HOME CARE SERVICES

CENTRAL NEBRASKA HOME CARE SERVICES

122017783

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
12201-001
Application Number
NDA206023
Marketing Category
NDA (C73594)
Route of Administration
RESPIRATORY (INHALATION)
Effective Date
December 27, 2017
OxygenActive
Code: S88TT14065Class: ACTIBQuantity: 210 mL in 1 L
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