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 Action	Adrenergic beta2-Agonists

Medical Subject Heading (MeSH) Categories for 022007

Adrenergic beta-2 Receptor Agonists
Bronchodilator Agents

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:	RX	Dosage:	SOLUTION;INHALATION			Strength	0.02MG/2ML
Approval Date:	May 11, 2007	TE:	AN	RLD:	Yes

Expired US Patents for NDA 022007

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

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