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Generated: April 18, 2019

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Details for New Drug Application (NDA): 021067

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NDA 021067 describes ASMANEX TWISTHALER, which is a drug marketed by Merck Sharp Dohme 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-one suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.
Summary for 021067
Tradename:ASMANEX TWISTHALER
Applicant:Merck Sharp Dohme
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 Merck Sharp & Dohme Corp. 0085-1341 0085-1341-01 1 POUCH in 1 CARTON (0085-1341-01) > 1 INHALER in 1 POUCH > 120 INHALANT in 1 INHALER
ASMANEX TWISTHALER mometasone furoate POWDER;INHALATION 021067 NDA Merck Sharp & Dohme Corp. 0085-1341 0085-1341-02 1 POUCH in 1 CARTON (0085-1341-02) > 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
Merck Sharp Dohme ASMANEX TWISTHALER mometasone furoate POWDER;INHALATION 021067-002 Feb 1, 2008 ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme ASMANEX TWISTHALER mometasone furoate POWDER;INHALATION 021067-002 Feb 1, 2008 ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme ASMANEX TWISTHALER mometasone furoate POWDER;INHALATION 021067-001 Mar 30, 2005 ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme ASMANEX TWISTHALER mometasone furoate POWDER;INHALATION 021067-002 Feb 1, 2008 ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme ASMANEX TWISTHALER mometasone furoate POWDER;INHALATION 021067-001 Mar 30, 2005 ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme ASMANEX TWISTHALER mometasone furoate POWDER;INHALATION 021067-002 Feb 1, 2008 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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