Citalopram Hydrobromide

ANDA 77654, held by Glenmark Pharms Ltd. Citalopram Hydrobromide.

As of Nov 15, 2026, ANDA 77654 (Citalopram Hydrobromide), held by Glenmark Pharms Ltd, was first approved by FDA on Feb 27, 2009, with 5 approved supplements and 0 published complete response letters.

First approved: Feb 27, 2009
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Feb 27, 2009	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 6 submissions, including labeling and manufacturing supplements


Oct 7, 2024	Supplement 5Labeling · Standard review	Approved	None posted
Nov 20, 2023	Supplement 4Labeling · Standard review	Approved	None posted
Sep 16, 2022	Supplement 1Labeling · Standard review	Approved	None posted
Sep 16, 2022	Supplement 2Labeling · Standard review	Approved	None posted
Sep 16, 2022	Supplement 3Labeling · Standard review	Approved	None posted
Feb 27, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 77654
Drugs@FDA: Overview at FDA
Company: Glenmark 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