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Generated: December 12, 2018

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Details for New Drug Application (NDA): 022007

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NDA 022007 describes PERFOROMIST, which is a drug marketed by Mylan Speclt and is included in one NDA. It is available from one supplier. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the PERFOROMIST profile page.

The generic ingredient in PERFOROMIST is formoterol fumarate. 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 profile page.
Summary for 022007
Tradename:PERFOROMIST
Applicant:Mylan Speclt
Ingredient:formoterol fumarate
Patents:6
Formulation / Manufacturing:see details
Pharmacology for NDA: 022007
Mechanism of ActionAdrenergic beta2-Agonists
Medical Subject Heading (MeSH) Categories for 022007
Suppliers and Packaging for NDA: 022007
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007 NDA Mylan Specialty L.P. 49502-605 49502-605-30 30 POUCH in 1 CARTON (49502-605-30) > 1 VIAL in 1 POUCH > 2 mL in 1 VIAL
PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007 NDA Mylan Specialty L.P. 49502-605 49502-605-61 60 POUCH in 1 CARTON (49502-605-61) > 1 VIAL in 1 POUCH (49502-605-95) > 2 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrength0.02MG/2ML
Approval Date:May 11, 2007TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jun 22, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Jun 22, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:MAINTENANCE TREATMENT OF BRONCHOCONSTRICTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Patent:➤ Sign UpPatent Expiration:Jun 22, 2021Product Flag?YSubstance Flag?Delist Request?

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