You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: June 13, 2024

Details for New Drug Application (NDA): 022518


✉ Email this page to a colleague

« Back to Dashboard


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
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:RXDosage:AEROSOL, METERED;INHALATIONStrength0.005MG/INH;0.1MG/INH
Approval Date:Jun 22, 2010TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;INHALATIONStrength0.005MG/INH;0.2MG/INH
Approval Date:Jun 22, 2010TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;INHALATIONStrength0.005MG/INH;0.05MG/INH
Approval Date:Aug 12, 2019TE:RLD:Yes

Expired US Patents for NDA 022518

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 022518-002 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
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.