Citalopram Hydrobromide

ANDA 77040, held by Chartwell Rx. Citalopram Hydrobromide.

As of Nov 15, 2026, ANDA 77040 (Citalopram Hydrobromide), held by Chartwell Rx, was first approved by FDA on Aug 17, 2005, with 1 approved supplement and 0 published complete response letters.

First approved: Aug 17, 2005
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Aug 17, 2005	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 2 submissions, including labeling and manufacturing supplements


Nov 14, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Aug 17, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 77040
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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