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Last Updated: November 22, 2024

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 two suppliers. 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. Thirteen suppliers are 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:0
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 AUTHORIZED GENERIC Mylan Pharmaceuticals Inc. 0378-1631 0378-1631-91 60 POUCH in 1 CARTON (0378-1631-91) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL
PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007 NDA AUTHORIZED GENERIC Mylan Pharmaceuticals Inc. 0378-1631 0378-1631-93 30 POUCH in 1 CARTON (0378-1631-93) / 1 VIAL in 1 POUCH (0378-1631-32) / 2 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrength0.02MG/2ML
Approval Date:May 11, 2007TE:ANRLD:Yes

Expired US Patents for NDA 022007

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Speclt PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007-001 May 11, 2007 ⤷  Sign Up ⤷  Sign Up
Mylan Speclt PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007-001 May 11, 2007 ⤷  Sign Up ⤷  Sign Up
Mylan Speclt PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007-001 May 11, 2007 ⤷  Sign Up ⤷  Sign Up
Mylan Speclt PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007-001 May 11, 2007 ⤷  Sign Up ⤷  Sign Up
Mylan Speclt PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007-001 May 11, 2007 ⤷  Sign Up ⤷  Sign Up
Mylan Speclt PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007-001 May 11, 2007 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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