Citalopram Hydrobromide

ANDA 77046, held by Apotex. Citalopram Hydrobromide.

As of Nov 15, 2026, ANDA 77046 (Citalopram Hydrobromide), held by Apotex, was first approved by FDA on Nov 24, 2004, with 15 approved supplements and 0 published complete response letters.

First approved: Nov 24, 2004
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Nov 24, 2004	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 16 submissions, including labeling and manufacturing supplements


Jun 3, 2024	Supplement 24Labeling · Standard review	Approved	None posted
Oct 5, 2022	Supplement 22Labeling · Standard review	Approved	None posted
Oct 5, 2022	Supplement 21Labeling · Standard review	Approved	None posted
Oct 5, 2022	Supplement 20Labeling · Standard review	Approved	None posted
Oct 5, 2022	Supplement 19Labeling · Standard review	Approved	None posted
Jul 27, 2016	Supplement 18Labeling · Standard review	Approved	None posted
Dec 5, 2014	Supplement 17Labeling · Standard review	Approved	None posted
Apr 25, 2012	Supplement 14Labeling	Approved	None posted
Jun 17, 2009	Supplement 12Labeling	Approved	None posted
Jun 17, 2009	Supplement 11Labeling	Approved	None posted
Dec 17, 2008	Supplement 10Labeling	Approved	None posted
Jun 28, 2007	Supplement 8Labeling	Approved	None posted
Mar 24, 2006	Supplement 3Labeling	Approved	None posted
Aug 26, 2005	Supplement 5Labeling	Approved	None posted
Apr 29, 2005	Supplement 4Labeling	Approved	None posted
Nov 24, 2004	Original application	Approved	None posted

Identifiers

Application: ANDA 77046
Drugs@FDA: Overview at FDA
Company: Apotex

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