Citalopram Hydrobromide

Treats depression. ANDA 77043, held by Hikma. Citalopram Hydrobromide.

As of Nov 15, 2026, ANDA 77043 (Citalopram Hydrobromide), held by Hikma, was first approved by FDA on Dec 13, 2004, with 13 approved supplements and 0 published complete response letters.

First approved: Dec 13, 2004
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
Dec 13, 2004	Original application	Approved	Letter

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 19Labeling · Standard review	Approved	None posted
Sep 21, 2021	Supplement 17Labeling · Standard review	Approved	None posted
Sep 3, 2021	Supplement 15Labeling · Standard review	Approved	None posted
Jan 4, 2017	Supplement 13Labeling · Standard review	Approved	None posted
Jul 17, 2014	Supplement 10Labeling · Standard review	Approved	Label
Jun 2, 2014	Supplement 9Labeling · Standard review	Approved	None posted
May 21, 2012	Supplement 7Labeling	Approved	None posted
May 21, 2012	Supplement 8Labeling	Approved	None posted
Apr 6, 2009	Supplement 6Labeling	Approved	None posted
Jul 2, 2008	Supplement 5Labeling	Approved	None posted
Oct 25, 2007	Supplement 3Labeling	Approved	None posted
Oct 25, 2007	Supplement 4Labeling	Approved	None posted
May 11, 2005	Supplement 1Labeling	Approved	None posted
Dec 13, 2004	Original application	Approved	Letter

Identifiers

Application: ANDA 77043
Drugs@FDA: Overview at FDA
Company: Hikma

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