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Last Updated: April 25, 2024

Details for New Drug Application (NDA): 021323

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NDA 021323 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-one suppliers are listed for this compound. Additional details are available on the escitalopram oxalate profile page.

Summary for 021323

Tradename:	LEXAPRO
Applicant:	Abbvie
Ingredient:	escitalopram oxalate
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021323

Mechanism of Action	Serotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 021323

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323	NDA	Allergan, Inc.	0456-2005	0456-2005-01	100 TABLET, FILM COATED in 1 BOTTLE (0456-2005-01)
LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323	NDA	Allergan, Inc.	0456-2010	0456-2010-01	100 TABLET, FILM COATED in 1 BOTTLE (0456-2010-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE
Approval Date:	Aug 14, 2002	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	May 12, 2026
Regulatory Exclusivity Use:	NEW PATIENT POPULATION

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Aug 14, 2002	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	May 12, 2026
Regulatory Exclusivity Use:	NEW PATIENT POPULATION

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 20MG BASE
Approval Date:	Aug 14, 2002	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	May 12, 2026
Regulatory Exclusivity Use:	NEW PATIENT POPULATION

Expired US Patents for NDA 021323

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-003	Aug 14, 2002	⤷ Try a Trial	⤷ Try a Trial
Abbvie	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-003	Aug 14, 2002	⤷ Try a Trial	⤷ Try a Trial
Abbvie	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-001	Aug 14, 2002	⤷ Try a Trial	⤷ Try a Trial
Abbvie	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-002	Aug 14, 2002	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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