Citalopram Hydrobromide

Treats depression. ANDA 77812, held by Aurobindo Pharma. Citalopram Hydrobromide.

As of Nov 15, 2026, ANDA 77812 (Citalopram Hydrobromide), held by Aurobindo Pharma, was first approved by FDA on Aug 28, 2006, with 13 approved supplements and 0 published complete response letters.

First approved: Aug 28, 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, USP is indicated for the treatment of depression. The efficacy of citalopram oral solution, USP 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
Aug 28, 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 22Labeling · Standard review	Approved	None posted
Sep 20, 2021	Supplement 17Labeling · Standard review	Approved	None posted
Sep 13, 2021	Supplement 14Labeling · Standard review	Approved	None posted
Jan 4, 2017	Supplement 12Labeling · Standard review	Approved	None posted
Jul 17, 2014	Supplement 11Labeling · Standard review	Approved	None posted
Jul 15, 2014	Supplement 10Labeling · Standard review	Approved	None posted
May 29, 2012	Supplement 7Labeling	Approved	None posted
May 29, 2012	Supplement 8Labeling · Standard review	Approved	None posted
Feb 25, 2009	Supplement 5Labeling	Approved	None posted
Jan 13, 2009	Supplement 4Labeling	Approved	None posted
Jul 2, 2008	Supplement 3Labeling	Approved	None posted
Oct 25, 2007	Supplement 2Labeling	Approved	None posted
Jul 2, 2007	Supplement 1Labeling	Approved	None posted
Aug 28, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 77812
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma

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