Celexa

Treats major depressive disorder (MDD). NDA 20822, held by Abbvie. Citalopram Hydrobromide.

As of Nov 13, 2026, NDA 20822 (Celexa), held by Abbvie, was first approved by FDA on Jul 17, 1998, with 33 approved supplements and 0 published complete response letters.

First approved: Jul 17, 1998
Review: Standard
Supplements approved: 33
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

CELEXA is indicated for the treatment of major depressive disorder (MDD) in adults.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 34 submissions below

Date	Submission	Status	Documents
Jul 17, 1998	Original applicationNew molecular entity · Standard review	Approved	Letter Review Label Pediatric Medical Review

Products

4 strengths and forms


CelexaEQ 10MG BASE · tablet;oral	Citalopram Hydrobromide	RxReference drug
CelexaEQ 20MG BASE · tablet;oral	Citalopram Hydrobromide	RxReference drug
CelexaEQ 40MG BASE · tablet;oral	Citalopram Hydrobromide	RxReference drug
CelexaEQ 60MG BASE · tablet;oral	Citalopram Hydrobromide	Discontinued

All 34 submissions, including labeling and manufacturing supplements


Apr 19, 2024	Supplement 55Labeling · Standard review	Approved	Medication Guide Label Letter
Aug 18, 2023	Supplement 54Labeling · Standard review	Approved	Letter Label
Feb 4, 2022	Supplement 41Labeling · Standard review	Approved	Letter Label
Sep 20, 2021	Supplement 52Labeling	Approved	Label Letter
Jan 11, 2019	Supplement 51Labeling · Standard review	Approved	Letter Label
Jan 4, 2017	Supplement 47Labeling	Approved	Letter Label
Jul 8, 2014	Supplement 46Labeling	Approved	Label Letter
Apr 16, 2014	Supplement 45Labeling · Standard review	Approved	Label Letter
Jun 17, 2013	Supplement 44Manufacturing · Standard review	Approved	None posted
Dec 3, 2012	Supplement 43Labeling · Standard review	Approved	Letter Label
Mar 27, 2012	Supplement 42Labeling · Standard review	Approved	Review Letter Label
Aug 12, 2011	Supplement 40Labeling	Approved	Review Letter Label
Aug 12, 2011	Supplement 38Labeling · Standard review	Approved	Review Letter Label
Jan 30, 2009	Supplement 37Labeling · Standard review	Approved	Label Letter
Sep 18, 2008	Supplement 35Labeling · Standard review	Approved	Letter Label
Aug 2, 2007	Supplement 34Labeling · Standard review	Approved	Letter Label
Feb 18, 2005	Supplement 29Labeling · Standard review	Approved	Label Letter
May 20, 2004	Supplement 27Labeling · Standard review	Approved	Letter
Apr 8, 2004	Supplement 23Labeling · Standard review	Approved	Letter
Nov 19, 2002	Supplement 19Labeling · Standard review	Approved	Review Letter
May 30, 2002	Supplement 15Manufacturing · Standard review	Approved	None posted
Jul 10, 2001	Supplement 14Manufacturing · Standard review	Approved	None posted
Jun 27, 2001	Supplement 11Labeling · Standard review	Approved	None posted
May 17, 2001	Supplement 13Manufacturing · Standard review	Approved	None posted
Nov 22, 2000	Supplement 12Manufacturing · Standard review	Approved	None posted
Jul 13, 2000	Supplement 7Manufacturing · Standard review	Approved	None posted
Jun 27, 2000	Supplement 10Manufacturing · Standard review	Approved	None posted
Apr 27, 2000	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 7, 1999	Supplement 6Manufacturing · Standard review	Approved	None posted
Dec 7, 1999	Supplement 5Manufacturing · Standard review	Approved	None posted
Oct 21, 1999	Supplement 3Manufacturing · Standard review	Approved	None posted
Oct 19, 1999	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 13, 1999	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 17, 1998	Original applicationNew molecular entity · Standard review	Approved	Letter Review Label Pediatric Medical Review

Identifiers

Application: NDA 20822
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