CITALOPRAM HYDROBROMIDEcitalopram hydrobromide

FDA approved the original new drug application for CITALOPRAM HYDROBROMIDE on December 20, 2005, sponsored by BIOVAIL LABS INTL. FDA marks 3 of the application’s 4 products discontinued and the other still marketed. FDA’s record shows no approved efficacy supplement on the application since.

Application

NDA021763

Sponsor

BIOVAIL LABS INTL

Original approval

December 20, 2005

Review

standard review

Submission class

Type 3 - New Dosage Form

Active ingredient

citalopram hydrobromide

Browse every approval whose brand starts with C, or the complete response letters FDA has published — the applications it did not approve.

Products under this application

What “discontinued” means in FDA’s record

Drugs@FDA marks a product discontinued when it was never marketed, when it has been taken off the market, when it is made only for export, when it is made for military use, or when its approval was withdrawn for a reason other than safety or effectiveness. The record does not say which of those applies to a given product. The word on its own is not evidence that FDA found the drug unsafe.

Source: FDA, Drugs@FDA glossary of terms, under “Discontinued Drug Product”.

Approved efficacy supplements

An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.

FDA’s record shows no approved efficacy supplement on this application.

Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.

Other approvals to BIOVAIL LABS INTL

• April 25, 2007TOVALT ODTNDA021412
• October 24, 1991CARDIZEMNDA020027
• February 9, 1988VASOTECNDA019309