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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 021067


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NDA 021067 describes ASMANEX TWISTHALER, 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 TWISTHALER profile page.

The generic ingredient in ASMANEX TWISTHALER 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 021067
Tradename:ASMANEX TWISTHALER
Applicant:Organon Llc
Ingredient:mometasone furoate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021067
Medical Subject Heading (MeSH) Categories for 021067
Suppliers and Packaging for NDA: 021067
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ASMANEX TWISTHALER mometasone furoate POWDER;INHALATION 021067 NDA Organon LLC 78206-114 78206-114-01 1 POUCH in 1 CARTON (78206-114-01) / 1 INHALER in 1 POUCH / 120 INHALANT in 1 INHALER
ASMANEX TWISTHALER mometasone furoate POWDER;INHALATION 021067 NDA Organon LLC 78206-114 78206-114-02 1 POUCH in 1 CARTON (78206-114-02) / 1 INHALER in 1 POUCH / 60 INHALANT in 1 INHALER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrength0.22MG/INH
Approval Date:Mar 30, 2005TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrength0.11MG/INH
Approval Date:Feb 1, 2008TE:RLD:Yes

Expired US Patents for NDA 021067

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon Llc ASMANEX TWISTHALER mometasone furoate POWDER;INHALATION 021067-001 Mar 30, 2005 ⤷  Try a Trial ⤷  Try a Trial
Organon Llc ASMANEX TWISTHALER mometasone furoate POWDER;INHALATION 021067-001 Mar 30, 2005 ⤷  Try a Trial ⤷  Try a Trial
Organon Llc ASMANEX TWISTHALER mometasone furoate POWDER;INHALATION 021067-002 Feb 1, 2008 ⤷  Try a Trial ⤷  Try a Trial
Organon Llc ASMANEX TWISTHALER mometasone furoate POWDER;INHALATION 021067-002 Feb 1, 2008 ⤷  Try a Trial ⤷  Try a Trial
Organon Llc ASMANEX TWISTHALER mometasone furoate POWDER;INHALATION 021067-001 Mar 30, 2005 ⤷  Try a Trial ⤷  Try a Trial
Organon Llc ASMANEX TWISTHALER mometasone furoate POWDER;INHALATION 021067-001 Mar 30, 2005 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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