Citalopram Hydrobromide

Treats major depressive disorder (MDD). ANDA 77289, held by Amneal Pharms Ny. Citalopram Hydrobromide.

As of Nov 15, 2026, ANDA 77289 (Citalopram Hydrobromide), held by Amneal Pharms Ny, was first approved by FDA on Nov 30, 2006, with 14 approved supplements and 0 published complete response letters.

First approved: Nov 30, 2006
Supplements approved: 14
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 15 submissions below

Date	Submission	Status	Documents
Nov 30, 2006	Original application	Approved	None posted

Products

3 strengths and forms


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

All 15 submissions, including labeling and manufacturing supplements


Sep 19, 2024	Supplement 34Labeling · Standard review	Approved	None posted
Jan 8, 2024	Supplement 20Labeling · Standard review	Approved	None posted
Jan 8, 2024	Supplement 24Labeling · Standard review	Approved	None posted
Jan 8, 2024	Supplement 29Labeling · Standard review	Approved	None posted
Jan 8, 2024	Supplement 31Labeling · Standard review	Approved	None posted
Jan 8, 2024	Supplement 32Labeling · Standard review	Approved	None posted
Jan 8, 2024	Supplement 33Labeling · Standard review	Approved	None posted
Nov 3, 2014	Supplement 15Labeling · Standard review	Approved	None posted
Nov 3, 2014	Supplement 18Labeling · Standard review	Approved	None posted
Nov 3, 2014	Supplement 19Labeling · Standard review	Approved	None posted
Apr 25, 2012	Supplement 8Labeling	Approved	None posted
Jan 13, 2011	Supplement 5Manufacturing	Approved	None posted
Apr 3, 2008	Supplement 3Labeling	Approved	None posted
Mar 20, 2008	Supplement 1Manufacturing	Approved	None posted
Nov 30, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 77289
Drugs@FDA: Overview at FDA
Company: Amneal Pharmaceuticals of New York

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