Citalopram Hydrobromide

Treats depression. ANDA 201450, held by Hetero Labs Ltd Iii. Citalopram Hydrobromide.

As of Nov 15, 2026, ANDA 201450 (Citalopram Hydrobromide), held by Hetero Labs Ltd Iii, was first approved by FDA on Dec 15, 2015, with 4 approved supplements and 0 published complete response letters.

First approved: Dec 15, 2015
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS & USAGE Citalopram oral solution, USP is indicated for the treatment of depression. The efficacy of citalopram oral solution, USP in the treatment of depression was established in 4 to 6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see CLINICAL PHARMACOLOGY ).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Dec 15, 2015	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Citalopram HydrobromideEQ 10MG BASE/5ML · solution;oral	Citalopram Hydrobromide	Rx

All 5 submissions, including labeling and manufacturing supplements


Aug 18, 2023	Supplement 6Labeling · Standard review	Approved	None posted
Sep 21, 2021	Supplement 4Labeling · Standard review	Approved	None posted
Sep 13, 2021	Supplement 1Labeling · Standard review	Approved	None posted
Apr 20, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Dec 15, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 201450
Drugs@FDA: Overview at FDA
Company: Hetero Labs Ltd Iii

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