Details for New Drug Application (NDA): 021365

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NDA 021365 describes LEXAPRO, which is a drug marketed by Abbvie and is included in two NDAs. It is available from one supplier. 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. Fifty suppliers are listed for this compound. Additional details are available on the escitalopram oxalate profile page.

Summary for 021365

Tradename:	LEXAPRO
Applicant:	Abbvie
Ingredient:	escitalopram oxalate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	EQ 5MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Nov 27, 2002	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	May 12, 2026
Regulatory Exclusivity Use:	NEW PATIENT POPULATION

Expired US Patents for NDA 021365

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	LEXAPRO	escitalopram oxalate	SOLUTION;ORAL	021365-001	Nov 27, 2002	RE34712*PED	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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