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HELIUM, USP

NDA · New Drug Application · Sponsor: ROBERTS OXYGEN CO INC · Approved 2019-07-14

Drug application

FDA Application #

NDA213609

Application type

New Drug Application

Brand name

HELIUM, USP

Generic name

HELIUM

Active ingredients

HELIUM

Dosage form

GAS

Route

INHALATION

Marketing status

Prescription

Sponsor

ROBERTS OXYGEN CO INC

Manufacturer

Roberts Oxygen Company, Inc.

First approval

2019-07-14

Source

Authoritative

Drugs@FDA application overview

Machine

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