Drug application

FAMOTIDINE (FAMOTIDINE)

Drugs@FDA ANDA 075611 · APOTEX

Key facts

Drug name FAMOTIDINE
Active ingredients FAMOTIDINE
Application type ANDA
Application number 075611
Company APOTEX
Dosage forms TABLET, ORAL
Strength 20MG
Marketing status Discontinued
TE codes AB
Reference listed drug No
Latest submission status date Jul 23, 2001

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • 10–99 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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