Details for New Drug Application (NDA): 022518

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NDA 022518 describes DULERA, 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 DULERA profile page.

The generic ingredient in DULERA is formoterol fumarate; mometasone furoate. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the formoterol fumarate; mometasone furoate profile page.

Summary for 022518

Tradename:	DULERA
Applicant:	Organon Llc
Ingredient:	formoterol fumarate; mometasone furoate
Patents:	0

Pharmacology for NDA: 022518

Mechanism of Action	Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 022518

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518	NDA	Organon LLC	78206-125	78206-125-01	1 CANISTER in 1 CARTON (78206-125-01) / 120 AEROSOL in 1 CANISTER
DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518	NDA	Organon LLC	78206-125	78206-125-59	1 CANISTER in 1 CARTON (78206-125-59) / 120 AEROSOL in 1 CANISTER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	AEROSOL, METERED;INHALATION			Strength	0.005MG/INH;0.1MG/INH
Approval Date:	Jun 22, 2010	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	AEROSOL, METERED;INHALATION			Strength	0.005MG/INH;0.2MG/INH
Approval Date:	Jun 22, 2010	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	AEROSOL, METERED;INHALATION			Strength	0.005MG/INH;0.05MG/INH
Approval Date:	Aug 12, 2019	TE:		RLD:	Yes

Expired US Patents for NDA 022518

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-001	Jun 22, 2010	⤷ Sign Up	⤷ Sign Up
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-001	Jun 22, 2010	⤷ Sign Up	⤷ Sign Up
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-002	Jun 22, 2010	⤷ Sign Up	⤷ Sign Up
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-002	Jun 22, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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