Citalopram Hydrobromide

ANDA 77035, held by Fosun Pharma. Citalopram Hydrobromide.

As of Nov 15, 2026, ANDA 77035 (Citalopram Hydrobromide), held by Fosun Pharma, was first approved by FDA on Oct 28, 2004, with 9 approved supplements and 0 published complete response letters.

First approved: Oct 28, 2004
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Oct 28, 2004	Original application	Approved	Letter

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 10 submissions, including labeling and manufacturing supplements


Nov 25, 2024	Supplement 12Labeling · Standard review	Approved	None posted
Nov 25, 2024	Supplement 13Labeling · Standard review	Approved	None posted
Mar 28, 2013	Supplement 11Labeling · Standard review	Approved	None posted
Dec 18, 2012	Supplement 10Labeling · Standard review	Approved	None posted
Sep 28, 2009	Supplement 9Labeling	Approved	None posted
Oct 19, 2007	Supplement 6Labeling	Approved	None posted
Oct 19, 2007	Supplement 8Labeling	Approved	None posted
Aug 1, 2005	Supplement 5Labeling	Approved	None posted
May 11, 2005	Supplement 4Labeling	Approved	None posted
Oct 28, 2004	Original application	Approved	Letter

Identifiers

Application: ANDA 77035
Drugs@FDA: Overview at FDA
Company: Fosun 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