Drug application

RANITIDINE HYDROCHLORIDE (RANITIDINE HYDROCHLORIDE)

Drugs@FDA ANDA 075294 · DR REDDYS LABS LTD

Key facts

Drug name RANITIDINE HYDROCHLORIDE
Active ingredients RANITIDINE HYDROCHLORIDE
Application type ANDA
Application number 075294
Company DR REDDYS LABS LTD
Dosage forms TABLET, ORAL
Strength EQ 75MG BASE
Marketing status Over-the-counter
Reference listed drug No
Latest submission status date Mar 28, 2000

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • None Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes FDA letters on file
  • No 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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