Drug application

ZANTAC 150 (RANITIDINE HYDROCHLORIDE)

Drugs@FDA NDA 021698 · CHATTEM SANOFI

Key facts

Drug name ZANTAC 150
Active ingredients RANITIDINE HYDROCHLORIDE
Application type NDA
Application number 021698
Company CHATTEM SANOFI
Dosage forms TABLET, ORAL
Strength EQ 150MG BASE
Marketing status Discontinued
Reference listed drug Yes
Latest submission class Type 3 - New Dosage Form
Latest submission status date Aug 31, 2004

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 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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