Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Indiana Oxygen Company Inc
006036776
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Indiana Oxygen Company Inc
Indiana Oxygen Company Inc
Indiana Oxygen Company Inc
006036776
Products4
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
48546-0002Application Number
NDA205767Marketing Category
NDA (C73594)Route of Administration
RESPIRATORY (INHALATION)Effective Date
February 11, 2022OxygenActive
Code: S88TT14065Class: ACTIBQuantity: 99.5 L in 100 L
OXYGEN
Product Details
NDC Product Code
48546-0006Application Number
NDA205767Marketing Category
NDA (C73594)Route of Administration
RESPIRATORY (INHALATION)Effective Date
February 11, 2022OxygenActive
Code: S88TT14065Class: ACTIBQuantity: 99 L in 100 L
OXYGEN
Product Details
NDC Product Code
48546-0004Application Number
NDA205767Marketing Category
NDA (C73594)Route of Administration
RESPIRATORY (INHALATION)Effective Date
February 11, 2022OxygenActive
Code: S88TT14065Class: ACTIBQuantity: 99.6 L in 100 L
OXYGEN
Product Details
NDC Product Code
48546-0001Application Number
NDA205767Marketing Category
NDA (C73594)Route of Administration
RESPIRATORY (INHALATION)Effective Date
February 11, 2022OxygenActive
Code: S88TT14065Class: ACTIBQuantity: 99 L in 100 L