Citalopram Hydrobromide

Treats major depressive disorder (MDD). ANDA 77042, held by Mylan. Citalopram Hydrobromide.

As of Nov 15, 2026, ANDA 77042 (Citalopram Hydrobromide), held by Mylan, was first approved by FDA on Nov 5, 2004, with 17 approved supplements and 0 published complete response letters.

First approved: Nov 5, 2004
Supplements approved: 17
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 18 submissions below

Date	Submission	Status	Documents
Nov 5, 2004	Original application	Approved	None posted

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 18 submissions, including labeling and manufacturing supplements


Sep 19, 2024	Supplement 43Labeling · Standard review	Approved	None posted
Sep 19, 2024	Supplement 38Labeling · Standard review	Approved	None posted
Sep 16, 2022	Supplement 34Labeling · Standard review	Approved	None posted
Sep 16, 2022	Supplement 33Labeling · Standard review	Approved	None posted
Sep 16, 2022	Supplement 28Labeling · Standard review	Approved	None posted
Sep 16, 2022	Supplement 25Labeling · Standard review	Approved	None posted
Dec 1, 2015	Supplement 24Labeling · Standard review	Approved	None posted
Apr 30, 2013	Supplement 20Labeling · Standard review	Approved	None posted
Apr 30, 2013	Supplement 18Labeling · Standard review	Approved	None posted
Apr 25, 2012	Supplement 17Labeling	Approved	None posted
Sep 28, 2009	Supplement 14Labeling	Approved	None posted
Jul 7, 2008	Supplement 13Labeling	Approved	None posted
Nov 1, 2007	Supplement 12Labeling	Approved	None posted
Nov 1, 2007	Supplement 11Labeling	Approved	None posted
Jun 27, 2007	Supplement 8Labeling	Approved	None posted
Aug 16, 2005	Supplement 2Labeling	Approved	None posted
Apr 29, 2005	Supplement 1Labeling	Approved	None posted
Nov 5, 2004	Original application	Approved	None posted

Identifiers

Application: ANDA 77042
Drugs@FDA: Overview at FDA
Company: Mylan

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