Citalopram Hydrobromide

ANDA 77036, held by Epic Pharma LLC. Citalopram Hydrobromide.

As of Nov 15, 2026, ANDA 77036 (Citalopram Hydrobromide), held by Epic Pharma LLC, was first approved by FDA on Oct 28, 2004, with 8 approved supplements and 0 published complete response letters.

First approved: Oct 28, 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
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 9 submissions, including labeling and manufacturing supplements


Nov 15, 2024	Supplement 8Labeling · Standard review	Approved	None posted
Nov 15, 2024	Supplement 7Labeling · Standard review	Approved	None posted
Sep 2, 2009	Supplement 6Labeling	Approved	None posted
Jul 2, 2008	Supplement 5Labeling	Approved	None posted
Oct 25, 2007	Supplement 4Labeling	Approved	None posted
Jun 27, 2007	Supplement 3Labeling	Approved	None posted
Jan 24, 2006	Supplement 2Labeling	Approved	None posted
Apr 29, 2005	Supplement 1Labeling	Approved	None posted
Oct 28, 2004	Original application	Approved	Letter

Identifiers

Application: ANDA 77036
Drugs@FDA: Overview at FDA
Company: Epic 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