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FDA NDA · NDA213609

HELIUM

Sponsor: ROBERTS OXYGEN CO INC

APPLICATION
NDA213609
TYPE
NDA
ORIGINAL APPROVAL
2019-07-14
LATEST ACTION
2019-07-14
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
GAS
MARKETING STATUS
Prescription

Products

HELIUM, USPPrescription
HELIUM N/A · GAS · INHALATION

Approval history

2019-07-14Medical Gas · Original · unknownLetterAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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