Citalopram Hydrobromide

Treats major depressive disorder (MDD). ANDA 78216, held by Torrent Pharms. Citalopram Hydrobromide.

As of Nov 15, 2026, ANDA 78216 (Citalopram Hydrobromide), held by Torrent Pharms, was first approved by FDA on Mar 27, 2007, with 16 approved supplements and 0 published complete response letters.

First approved: Mar 27, 2007
Supplements approved: 16
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 17 submissions below

Date	Submission	Status	Documents
Mar 27, 2007	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 17 submissions, including labeling and manufacturing supplements


Sep 18, 2024	Supplement 40Labeling · Standard review	Approved	None posted
Sep 18, 2024	Supplement 39Labeling · Standard review	Approved	None posted
Mar 28, 2024	Supplement 37Labeling · Standard review	Approved	None posted
Oct 5, 2022	Supplement 34Labeling · Standard review	Approved	None posted
Oct 5, 2022	Supplement 33Labeling · Standard review	Approved	None posted
Oct 5, 2022	Supplement 32Labeling · Standard review	Approved	None posted
Oct 5, 2022	Supplement 29Labeling · Standard review	Approved	None posted
Dec 10, 2014	Supplement 22Labeling · Standard review	Approved	None posted
Mar 28, 2013	Supplement 20Labeling · Standard review	Approved	None posted
Jun 26, 2012	Supplement 18Labeling · Standard review	Approved	None posted
Jun 26, 2012	Supplement 16Labeling	Approved	None posted
Jan 20, 2011	Supplement 9Labeling	Approved	None posted
Jun 22, 2009	Supplement 10Labeling	Approved	None posted
Jan 23, 2009	Supplement 7Labeling	Approved	None posted
Aug 13, 2008	Supplement 3Labeling	Approved	None posted
Oct 25, 2007	Supplement 1Labeling	Approved	None posted
Mar 27, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 78216
Drugs@FDA: Overview at FDA
Company: Torrent Pharmaceuticals

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