Citalopram Hydrobromide

Treats major depressive disorder (MDD). ANDA 77031, held by Aurobindo. Citalopram Hydrobromide.

As of Nov 15, 2026, ANDA 77031 (Citalopram Hydrobromide), held by Aurobindo, was first approved by FDA on Oct 28, 2004, with 20 approved supplements and 0 published complete response letters.

First approved: Oct 28, 2004
Supplements approved: 20
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Citalopram tablets are 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 21 submissions below

Date	Submission	Status	Documents
Oct 28, 2004	Original application	Approved	Letter

Products

3 strengths and forms


Citalopram HydrobromideEQ 10MG BASE · tablet;oral	Citalopram Hydrobromide	Rx
Citalopram HydrobromideEQ 20MG BASE · tablet;oral	Citalopram Hydrobromide	Rx
Citalopram HydrobromideEQ 40MG BASE · tablet;oral	Citalopram Hydrobromide	Rx

All 21 submissions, including labeling and manufacturing supplements


Jul 29, 2024	Supplement 44Labeling · Standard review	Approved	None posted
Oct 30, 2023	Supplement 43Labeling · Standard review	Approved	None posted
Aug 31, 2022	Supplement 38Labeling · Standard review	Approved	None posted
Aug 31, 2022	Supplement 37Labeling · Standard review	Approved	None posted
Aug 31, 2022	Supplement 33Labeling · Standard review	Approved	None posted
Aug 31, 2022	Supplement 31Labeling · Standard review	Approved	None posted
Sep 26, 2014	Supplement 30Labeling · Standard review	Approved	None posted
Sep 26, 2014	Supplement 29Labeling · Standard review	Approved	None posted
Apr 30, 2013	Supplement 23Labeling · Standard review	Approved	None posted
Apr 25, 2012	Supplement 21Labeling · Standard review	Approved	None posted
Apr 25, 2012	Supplement 18Labeling	Approved	None posted
Mar 6, 2009	Supplement 14Labeling	Approved	None posted
Jan 14, 2009	Supplement 11Labeling	Approved	None posted
Jul 2, 2008	Supplement 10Labeling	Approved	None posted
Oct 25, 2007	Supplement 9Labeling	Approved	None posted
Oct 25, 2007	Supplement 8Labeling	Approved	None posted
Jun 28, 2007	Supplement 6Labeling	Approved	None posted
Apr 9, 2007	Supplement 4Labeling	Approved	None posted
Apr 7, 2006	Supplement 2Labeling	Approved	None posted
Feb 6, 2006	Supplement 1Labeling	Approved	None posted
Oct 28, 2004	Original application	Approved	Letter

Identifiers

Application: ANDA 77031
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma

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