← FDA DRUG APPROVALS

FDA NDA · NDA021763

CITALOPRAM HYDROBROMIDE

Sponsor: BIOVAIL LABS INTL

APPLICATION
NDA021763
TYPE
NDA
ORIGINAL APPROVAL
2005-12-20
LATEST ACTION
2005-12-20
ROUTE
ORALLY DISINTEGRATING, ORAL
DOSAGE FORM
TABLET, TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription, Discontinued

Products

CITALOPRAM HYDROBROMIDEPrescription
CITALOPRAM HYDROBROMIDE 40MG · TABLET · ORALLY DISINTEGRATING
CITALOPRAM HYDROBROMIDE · ReferenceDiscontinued
CITALOPRAM HYDROBROMIDE EQ 20MG BASE · TABLET, ORALLY DISINTEGRATING · ORAL
CITALOPRAM HYDROBROMIDE · ReferenceDiscontinued
CITALOPRAM HYDROBROMIDE EQ 40MG BASE · TABLET, ORALLY DISINTEGRATING · ORAL
CITALOPRAM HYDROBROMIDE · ReferenceDiscontinued
CITALOPRAM HYDROBROMIDE EQ 10MG BASE · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2005-12-20Type 3 - New Dosage Form · Original · standardReviewAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →