Citalopram Hydrobromide

ANDA 77278, held by Taro. Citalopram Hydrobromide.

As of Nov 15, 2026, ANDA 77278 (Citalopram Hydrobromide), held by Taro, was first approved by FDA on Mar 22, 2006, with 2 approved supplements and 0 published complete response letters.

First approved: Mar 22, 2006
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Mar 22, 2006	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 3 submissions, including labeling and manufacturing supplements


Nov 15, 2024	Supplement 3Labeling · Standard review	Approved	None posted
Aug 21, 2009	Supplement 2Labeling	Approved	None posted
Mar 22, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 77278
Drugs@FDA: Overview at FDA
Company: Taro 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