Citalopram Hydrobromide

ANDA 77052, held by Sun Pharm Industries. Citalopram Hydrobromide.

As of Nov 15, 2026, ANDA 77052 (Citalopram Hydrobromide), held by Sun Pharm Industries, was first approved by FDA on Jul 3, 2006, with 1 approved supplement and 0 published complete response letters.

First approved: Jul 3, 2006
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
Jul 3, 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 2 submissions, including labeling and manufacturing supplements


Jun 28, 2007	Supplement 4Labeling	Approved	None posted
Jul 3, 2006	Original application	Approved	None posted

Identifiers

Application: ANDA 77052
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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