Citalopram Hydrobromide

ANDA 205407, held by Jubilant Generics. Citalopram Hydrobromide.

As of Nov 15, 2026, ANDA 205407 (Citalopram Hydrobromide), held by Jubilant Generics, was first approved by FDA on Dec 23, 2015, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 23, 2015
Review: Standard
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
Dec 23, 2015	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 4 submissions, including labeling and manufacturing supplements


Nov 14, 2024	Supplement 1Labeling · Standard review	Approved	None posted
Nov 14, 2024	Supplement 6Labeling · Standard review	Approved	None posted
Nov 14, 2024	Supplement 9Labeling · Standard review	Approved	None posted
Dec 23, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 205407
Drugs@FDA: Overview at FDA
Company: Jubilant Generics

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