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Details for New Drug Application (NDA): 021365

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NDA 021365 describes LEXAPRO, which is a drug marketed by Forest Labs 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-five drug master file entries for this compound. Fifty-nine suppliers are listed for this compound. There are eighteen tentative approvals for this compound. Additional details are available on the escitalopram oxalate profile page.

Summary for NDA: 021365

Tradename:
LEXAPRO
Applicant:
Forest Labs
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 0456-2101-08 240 mL in 1 BOTTLE (0456-2101-08)
LEXAPRO
escitalopram oxalate
SOLUTION;ORAL 021365 NDA Actavis Pharma, Inc. 0591-4151 0591-4151-38 240 mL in 1 BOTTLE (0591-4151-38)

Summary for product number 001

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

Expired Orange Book Patents for NDA: 021365

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Forest Labs
LEXAPRO
escitalopram oxalate
SOLUTION;ORAL021365-001Nov 27, 2002RE34712*PED► subscribe
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