Citalopram Hydrobromide

ANDA 77668, held by Pharmobedient. Citalopram Hydrobromide.

As of Nov 15, 2026, ANDA 77668 (Citalopram Hydrobromide), held by Pharmobedient, was first approved by FDA on Feb 28, 2007, with 6 approved supplements and 0 published complete response letters.

First approved: Feb 28, 2007
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Feb 28, 2007	Original application	Approved	None posted

Products

3 strengths and forms


Citalopram HydrobromideEQ 10MG BASE · capsule;oral	Citalopram Hydrobromide	Discontinued
Citalopram HydrobromideEQ 20MG BASE · capsule;oral	Citalopram Hydrobromide	Discontinued
Citalopram HydrobromideEQ 40MG BASE · capsule;oral	Citalopram Hydrobromide	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Nov 26, 2024	Supplement 7Labeling · Standard review	Approved	None posted
Jul 17, 2014	Supplement 6Labeling · Standard review	Approved	Label
Apr 6, 2009	Supplement 3Labeling	Approved	None posted
Feb 13, 2009	Supplement 4Labeling	Approved	None posted
Sep 24, 2008	Supplement 2Labeling	Approved	None posted
Oct 22, 2007	Supplement 1Labeling	Approved	None posted
Feb 28, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 77668
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