Citalopram Hydrobromide

ANDA 77034, held by Heritage Pharma. Citalopram Hydrobromide.

As of Nov 15, 2026, ANDA 77034 (Citalopram Hydrobromide), held by Heritage Pharma, was first approved by FDA on Jun 30, 2005, with 4 approved supplements and 0 published complete response letters.

First approved: Jun 30, 2005
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jun 30, 2005	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 5 submissions, including labeling and manufacturing supplements


Sep 30, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Aug 8, 2023	Supplement 3Labeling · Standard review	Approved	None posted
Aug 21, 2009	Supplement 2Labeling	Approved	None posted
Oct 21, 2008	Supplement 1Labeling	Approved	None posted
Jun 30, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 77034
Drugs@FDA: Overview at FDA
Company: Heritage Pharmaceuticals

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