Drug application

CITALOPRAM HYDROBROMIDE (CITALOPRAM HYDROBROMIDE)

Drugs@FDA NDA 021763 · BIOVAIL LABS INTL

Key facts

Drug name CITALOPRAM HYDROBROMIDE
Active ingredients CITALOPRAM HYDROBROMIDE
Application type NDA
Application number 021763
Company BIOVAIL LABS INTL
Dosage forms TABLET, ORALLY DISINTEGRATING, ORAL
Strength EQ 10MG BASE
Marketing status Discontinued
Reference listed drug Yes
Latest submission class Type 3 - New Dosage Form
Latest submission status date Dec 20, 2005

At a glance

  • 1–9 Submissions
  • 1–9 Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes FDA letters on file
  • Yes FDA reviews on file

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date:

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