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Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021365

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NDA 021365 describes LEXAPRO, which is a drug marketed by Allergan Sales Llc and is included in two NDAs. It is available from fourteen suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the LEXAPRO profile page.

The generic ingredient in LEXAPRO is escitalopram oxalate. There are twenty-six drug master file entries for this compound. Sixty-three suppliers are listed for this compound. Additional details are available on the escitalopram oxalate profile page.
Summary for 021365
Tradename:LEXAPRO
Applicant:Allergan Sales Llc
Ingredient:escitalopram oxalate
Patents:0
Therapeutic Class:Antidepressants
Anxiolytics
Pharmacology for NDA: 021365
Mechanism of ActionSerotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 021365
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEXAPRO escitalopram oxalate SOLUTION;ORAL 021365 NDA Allergan, Inc. 0456-2101 N 0456-2101-08

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrengthEQ 5MG BASE/5ML
Approval Date:Nov 27, 2002TE:AARLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
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McKinsey
Colorcon
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US Army
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