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Last Updated: August 11, 2022

Details for New Drug Application (NDA): 205641

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NDA 205641 describes ASMANEX HFA, which is a drug marketed by Organon and is included in one NDA. Additional details are available on the ASMANEX HFA profile page.

The generic ingredient in ASMANEX HFA is mometasone furoate. There are thirty drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.

Summary for 205641

Tradename:	ASMANEX HFA
Applicant:	Organon
Ingredient:	mometasone furoate
Patents:	0
Formulation / Manufacturing:	see details

Medical Subject Heading (MeSH) Categories for 205641

Anti-Allergic Agents
Anti-Inflammatory Agents
Dermatologic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	AEROSOL, METERED;INHALATION			Strength	0.10MG/INH
Approval Date:	Apr 25, 2014	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	AEROSOL, METERED;INHALATION			Strength	0.20MG/INH
Approval Date:	Apr 25, 2014	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	AEROSOL, METERED;INHALATION			Strength	0.05MG/INH
Approval Date:	Aug 12, 2019	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Aug 12, 2022
Regulatory Exclusivity Use:	NEW STRENGTH

Expired US Patents for NDA 205641

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-002	Apr 25, 2014	See Plans and Pricing	See Plans and Pricing
Organon	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-001	Apr 25, 2014	See Plans and Pricing	See Plans and Pricing
Organon	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-001	Apr 25, 2014	See Plans and Pricing	See Plans and Pricing
Organon	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-002	Apr 25, 2014	See Plans and Pricing	See Plans and Pricing
Organon	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-001	Apr 25, 2014	See Plans and Pricing	See Plans and Pricing
Organon	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-002	Apr 25, 2014	See Plans and Pricing	See Plans and Pricing
Organon	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-001	Apr 25, 2014	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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