Oxygen

Oxygen

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

Company

T.W. Smith Corp.

DUNS: 001853126

Effective Date

October 15, 2018

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Oxygen(99.9 L in 1 L)

Manufacturing Establishments1

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

Labeler

T.W. Smith Corp.

DUNS Number

001853126

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

NDC Product Code

52563-001

Application Number

NDA205849

Marketing Category

NDA (C73594)

Route of Administration

RESPIRATORY (INHALATION)

Effective Date

October 15, 2018

Ingredients

Code: S88TT14065Class: ACTIBQuantity: 99.9 L in 1 L