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FDA Product

ASMANEX HFA

Product approved by U.S. Food and Drug Administration (US)

Basic Information

ASMANEX HFA

78206-113

Regulatory Information

78206-113

NDA205641

C73594

June 1, 2021

USA

These highlights do not include all the information needed to use ASMANEX HFA safely and effectively. See full prescribing information for ASMANEX HFA. ASMANEX® HFA (mometasone furoate) inhalation aerosol, for oral inhalation use Initial U.S. Approval: 1987

HUMAN PRESCRIPTION DRUG LABEL

3

Company Information

Organon LLC

117494753

Active Ingredients

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

OLEIC ACID

Code: 2UMI9U37CP

Class Code: IACT

APAFLURANE

Code: R40P36GDK6

Class Code: IACT

MOMETASONE FUROATE

Quantity: 200 ug in 1 1

Code: 04201GDN4R

Class Code: ACTIB

Active Moieties

MOMETASONE

Code: 8HR4QJ6DW8

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