Details for New Drug Application (NDA): 205641

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NDA 205641 describes ASMANEX HFA, which is a drug marketed by Organon Llc and is included in one NDA. It is available from one supplier. 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. Twenty-three suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.

Summary for 205641

Tradename:	ASMANEX HFA
Applicant:	Organon Llc
Ingredient:	mometasone furoate
Patents:	0

Pharmacology for NDA: 205641

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 205641

Anti-Allergic Agents
Anti-Inflammatory Agents
Dermatologic Agents

Suppliers and Packaging for NDA: 205641

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641	NDA	Organon LLC	78206-111	78206-111-01	1 CANISTER in 1 CARTON (78206-111-01) / 120 AEROSOL in 1 CANISTER
ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641	NDA	Organon LLC	78206-111	78206-111-59	1 CANISTER in 1 CARTON (78206-111-59) / 120 AEROSOL in 1 CANISTER

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

Expired US Patents for NDA 205641

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Llc	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-001	Apr 25, 2014	⤷ Sign Up	⤷ Sign Up
Organon Llc	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-001	Apr 25, 2014	⤷ Sign Up	⤷ Sign Up
Organon Llc	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-002	Apr 25, 2014	⤷ Sign Up	⤷ Sign Up
Organon Llc	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-001	Apr 25, 2014	⤷ Sign Up	⤷ Sign Up
Organon Llc	ASMANEX HFA	mometasone furoate	AEROSOL, METERED;INHALATION	205641-002	Apr 25, 2014	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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