Citalopram Hydrobromide

ANDA 77037, held by Pharmobedient. Citalopram Hydrobromide.

As of Nov 15, 2026, ANDA 77037 (Citalopram Hydrobromide), held by Pharmobedient, 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	Discontinued
Citalopram HydrobromideEQ 20MG BASE · tablet;oral	Citalopram Hydrobromide	Discontinued
Citalopram HydrobromideEQ 40MG BASE · tablet;oral	Citalopram Hydrobromide	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Nov 25, 2024	Supplement 9Labeling · Standard review	Approved	None posted
Jun 17, 2024	Supplement 7Labeling · Standard review	Approved	None posted
Jun 17, 2024	Supplement 8Labeling · Standard review	Approved	None posted
Mar 30, 2009	Supplement 5Labeling	Approved	None posted
Sep 24, 2008	Supplement 4Labeling	Approved	None posted
Oct 22, 2007	Supplement 3Labeling	Approved	None posted
Feb 14, 2006	Supplement 2Labeling	Approved	None posted
Aug 1, 2005	Supplement 1Labeling	Approved	None posted
Nov 5, 2004	Original application	Approved	None posted

Identifiers

Application: ANDA 77037
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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