Citalopram Hydrobromide

ANDA 77601, held by Pharm Assoc. Citalopram Hydrobromide.

As of Nov 15, 2026, ANDA 77601 (Citalopram Hydrobromide), held by Pharm Assoc, was first approved by FDA on Nov 15, 2005, with 7 approved supplements and 0 published complete response letters.

First approved: Nov 15, 2005
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Nov 15, 2005	Original application	Approved	None posted

Products

1 strengths and forms

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

All 8 submissions, including labeling and manufacturing supplements


Aug 18, 2023	Supplement 9Labeling · Standard review	Approved	None posted
Sep 21, 2021	Supplement 8Labeling · Standard review	Approved	None posted
Sep 13, 2021	Supplement 7Labeling · Standard review	Approved	None posted
Jan 4, 2017	Supplement 6Labeling · Standard review	Approved	None posted
Jul 7, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Jul 17, 2014	Supplement 4Labeling · Standard review	Approved	None posted
Jul 11, 2014	Supplement 3Labeling · Standard review	Approved	None posted
Nov 15, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 77601
Drugs@FDA: Overview at FDA
Company: Pharmaceutical Associates

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