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Generated: September 20, 2017

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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 five 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 seventeen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the formoterol fumarate profile page.

Summary for NDA: 022007

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:5
Formulation / Manufacturing:see details

Pharmacology for NDA: 022007

Mechanism of ActionAdrenergic beta2-Agonists

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

Summary for product number 001

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


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Serving 500+ biopharmaceutical companies globally:

Cerilliant
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Federal Trade Commission
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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