Drug application

CITALOPRAM HYDROBROMIDE (CITALOPRAM HYDROBROMIDE)

Drugs@FDA NDA 215428 · ALMATICA

Key facts

Drug name CITALOPRAM HYDROBROMIDE
Active ingredients CITALOPRAM HYDROBROMIDE
Application type NDA
Application number 215428
Company ALMATICA
Dosage forms CAPSULE, ORAL
Strength EQ 30MG BASE
Marketing status Prescription
TE codes AB
Reference listed drug Yes
Latest submission class Type 2 - New Active Ingredient and Type 3 - New Dosage Form
Latest submission status date Jan 31, 2022

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • 1–9 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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