Citalopram Hydrobromide

Treats depression. ANDA 77629, held by Chartwell Molecular. Citalopram Hydrobromide.

As of Nov 15, 2026, ANDA 77629 (Citalopram Hydrobromide), held by Chartwell Molecular, was first approved by FDA on Jun 14, 2006, with 13 approved supplements and 0 published complete response letters.

First approved: Jun 14, 2006
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Citalopram Oral Solution is indicated for the treatment of depression. The efficacy of Citalopram Oral Solution in the treatment of depression was established in 4 to 6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder ( see CLINICAL PHARMACOLOGY ).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Jun 14, 2006	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Citalopram HydrobromideEQ 10MG BASE/5ML · solution;oral	Citalopram Hydrobromide	Rx

All 14 submissions, including labeling and manufacturing supplements


Aug 18, 2023	Supplement 18Labeling · Standard review	Approved	None posted
Sep 21, 2021	Supplement 16Labeling · Standard review	Approved	None posted
Sep 13, 2021	Supplement 14Labeling · Standard review	Approved	None posted
Sep 13, 2021	Supplement 15Labeling · Standard review	Approved	None posted
Jan 4, 2017	Supplement 13Labeling · Standard review	Approved	None posted
Jul 17, 2014	Supplement 11Labeling · Standard review	Approved	None posted
Nov 1, 2013	Supplement 7Labeling · Standard review	Approved	None posted
Nov 1, 2013	Supplement 8Labeling · Standard review	Approved	None posted
May 21, 2012	Supplement 5Labeling	Approved	None posted
Mar 11, 2009	Supplement 4Labeling	Approved	None posted
Jul 2, 2008	Supplement 3Labeling	Approved	None posted
Jul 12, 2007	Supplement 1Labeling	Approved	None posted
Jul 2, 2007	Supplement 2Labeling	Approved	None posted
Jun 14, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 77629
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