Citalopram Hydrobromide

ANDA 77232, held by Heritage Pharma. Citalopram Hydrobromide.

As of Nov 15, 2026, ANDA 77232 (Citalopram Hydrobromide), held by Heritage Pharma, was first approved by FDA on Oct 31, 2005, with 3 approved supplements and 0 published complete response letters.

First approved: Oct 31, 2005
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Oct 31, 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 4 submissions, including labeling and manufacturing supplements


Oct 7, 2024	Supplement 6Labeling · Standard review	Approved	None posted
Mar 2, 2023	Supplement 5Labeling · Standard review	Approved	None posted
Apr 26, 2011	Supplement 4Labeling	Approved	None posted
Oct 31, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 77232
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