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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 two suppliers. There are four patents protecting this drug. Additional details are available on the ASMANEX TWISTHALER profile page.

The generic ingredient in ASMANEX TWISTHALER is mometasone furoate. There are twenty-seven drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.

Summary for NDA: 021067

Tradename:
ASMANEX TWISTHALER
Applicant:
Merck Sharp Dohme
Ingredient:
mometasone furoate
Patents:4
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for NDA: 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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrength0.22MG/INH
Approval Date:Mar 30, 2005TE:RLD:Yes
Patent:5,829,434*PEDPatent Expiration:May 3, 2016Product Flag?Substance Flag?Delist Request?Y
Patent:6,240,918*PEDPatent Expiration:Aug 20, 2017Product Flag?Substance Flag?Delist Request?Y
Patent:6,503,537*PEDPatent Expiration:Sep 17, 2018Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021067

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
ASMANEX TWISTHALER
mometasone furoate
POWDER;INHALATION021067-001Mar 30, 20056,677,322*PED► subscribe
Merck Sharp Dohme
ASMANEX TWISTHALER
mometasone furoate
POWDER;INHALATION021067-001Mar 30, 20055,829,434*PED► subscribe
Merck Sharp Dohme
ASMANEX TWISTHALER
mometasone furoate
POWDER;INHALATION021067-002Feb 1, 20085,394,868*PED► subscribe
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