Citalopram Hydrobromide

ANDA 77044, held by Chartwell Molecular. Citalopram Hydrobromide.

As of Nov 15, 2026, ANDA 77044 (Citalopram Hydrobromide), held by Chartwell Molecular, was first approved by FDA on Nov 5, 2004, with 8 approved supplements and 0 published complete response letters.

First approved: Nov 5, 2004
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 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 9 submissions, including labeling and manufacturing supplements


Nov 26, 2024	Supplement 7Labeling · Standard review	Approved	None posted
Nov 26, 2024	Supplement 8Labeling · Standard review	Approved	None posted
Nov 8, 2016	Supplement 6Labeling · Standard review	Approved	None posted
Aug 31, 2009	Supplement 5Labeling	Approved	None posted
Oct 22, 2008	Supplement 4Labeling	Approved	None posted
Apr 3, 2008	Supplement 3Labeling	Approved	None posted
Jul 2, 2007	Supplement 2Labeling	Approved	None posted
Jun 9, 2005	Supplement 1Labeling	Approved	None posted
Nov 5, 2004	Original application	Approved	None posted

Identifiers

Application: ANDA 77044
Drugs@FDA: Overview at FDA
Company: Chartwell Molecular

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