Citalopram Hydrobromide

ANDA 77141, held by Natco Pharma Ltd. Citalopram Hydrobromide.

As of Nov 15, 2026, ANDA 77141 (Citalopram Hydrobromide), held by Natco Pharma Ltd, was first approved by FDA on Apr 10, 2008, with 3 approved supplements and 0 published complete response letters.

First approved: Apr 10, 2008
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
Apr 10, 2008	Original application	Approved	None posted

Products

2 strengths and forms


Citalopram HydrobromideEQ 40MG BASE · tablet;oral	Citalopram Hydrobromide	Discontinued
Citalopram HydrobromideEQ 20MG BASE · tablet;oral	Citalopram Hydrobromide	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Sep 18, 2024	Supplement 3Labeling · Standard review	Approved	None posted
Jan 21, 2011	Supplement 2Labeling	Approved	None posted
Jul 2, 2010	Supplement 1Labeling	Approved	None posted
Apr 10, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 77141
Drugs@FDA: Overview at FDA
Company: Natco 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