Lexapro

Treats major depressive disorder (MDD). NDA 21323, held by Abbvie. Escitalopram Oxalate.

As of Nov 15, 2026, NDA 21323 (Lexapro), held by Abbvie, was first approved by FDA on Aug 14, 2002, with 29 approved supplements and 0 published complete response letters.

First approved: Aug 14, 2002
Review: Standard
Supplements approved: 29
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Lexapro is indicated for the treatment of:

major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older.
generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older. Lexapro is a selective serotonin reuptake inhibitor (SSRI) indicated for the: treatment of major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older treatment of generalized anxiety disorder (GAD) in adults and pediatric patients 7 years and older

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 30 submissions below


May 12, 2023	Supplement 55Efficacy (new indication or use) · Standard review	Approved	Letter Label Medication Guide
Mar 19, 2009	Supplement 31Efficacy (new indication or use)	Approved	Review Label Letter
Mar 19, 2009	Supplement 30Efficacy (new indication or use)	Approved	Review Label Letter
Dec 18, 2003	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Dec 18, 2003	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Aug 29, 2002	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Label Review Letter
Aug 14, 2002	Original applicationNew dosage form · Standard review	Approved	Review Letter Label Pediatric Medical Review

Products

3 strengths and forms


LexaproEQ 5MG BASE · tablet;oral	Escitalopram Oxalate	RxReference drug
LexaproEQ 10MG BASE · tablet;oral	Escitalopram Oxalate	RxReference drug
LexaproEQ 20MG BASE · tablet;oral	Escitalopram Oxalate	RxReference drug

All 30 submissions, including labeling and manufacturing supplements


Apr 19, 2024	Supplement 58Labeling · Standard review	Approved	Medication Guide Label Letter
Aug 18, 2023	Supplement 57Labeling · Standard review	Approved	Letter Label Medication Guide
May 12, 2023	Supplement 55Efficacy (new indication or use) · Standard review	Approved	Letter Label Medication Guide
Sep 20, 2021	Supplement 53Labeling	Approved	Label Letter
Aug 28, 2020	Supplement 52Labeling · Standard review	Approved	Label Letter
Jan 11, 2019	Supplement 51Labeling · Standard review	Approved	Letter Label
Jan 4, 2017	Supplement 47Labeling	Approved	Letter Label
Jan 28, 2016	Supplement 46Manufacturing · Standard review	Approved	None posted
Oct 31, 2014	Supplement 44Labeling · Standard review	Approved	Label Letter Pediatric Clinical Pharmacology Review Pediatric Statistical Review
Jul 8, 2014	Supplement 45Labeling	Approved	Label Letter
May 29, 2013	Supplement 43Manufacturing · Standard review	Approved	None posted
Mar 7, 2013	Supplement 39Manufacturing · Standard review	Approved	None posted
Dec 3, 2012	Supplement 40Labeling · Standard review	Approved	Letter Label
May 12, 2011	Supplement 33Labeling · Standard review	Approved	Letter Label
Mar 11, 2011	Supplement 35Labeling	Approved	Letter Label
Mar 19, 2009	Supplement 31Efficacy (new indication or use)	Approved	Review Label Letter
Mar 19, 2009	Supplement 30Efficacy (new indication or use)	Approved	Review Label Letter
Jan 30, 2009	Supplement 32Labeling · Standard review	Approved	Label Letter
Oct 11, 2008	Supplement 29Labeling · Standard review	Approved	Letter
Sep 18, 2008	Supplement 28Labeling · Standard review	Approved	Letter Label
Aug 2, 2007	Supplement 25Labeling · Standard review	Approved	Letter Label
Feb 18, 2005	Supplement 20Labeling · Standard review	Approved	Letter
Jan 11, 2005	Supplement 14Labeling · Standard review	Approved	Letter
May 20, 2004	Supplement 15Labeling · Standard review	Approved	Letter
Apr 8, 2004	Supplement 10	Approved	None posted
Dec 18, 2003	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Dec 18, 2003	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Dec 13, 2002	Supplement 2Manufacturing · Standard review	Approved	None posted
Aug 29, 2002	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Label Review Letter
Aug 14, 2002	Original applicationNew dosage form · Standard review	Approved	Review Letter Label Pediatric Medical Review

Identifiers

Application: NDA 21323
Drugs@FDA: Overview at FDA
Company: AbbVie

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters