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Last Updated: March 28, 2024

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
Formulation / Manufacturing:see details
Pharmacology for NDA: 205641
Medical Subject Heading (MeSH) Categories for 205641
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:RXDosage:AEROSOL, METERED;INHALATIONStrength0.10MG/INH
Approval Date:Apr 25, 2014TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;INHALATIONStrength0.20MG/INH
Approval Date:Apr 25, 2014TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;INHALATIONStrength0.05MG/INH
Approval Date:Aug 12, 2019TE:RLD:Yes

Expired US Patents for NDA 205641

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

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