Drug application

FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE (CALCIUM CARBONATE, FAMOTIDINE, MAGNESIUM HYDROXIDE)

Drugs@FDA ANDA 077355 · PERRIGO R AND D

Key facts

Drug name FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE
Active ingredients CALCIUM CARBONATE, FAMOTIDINE, MAGNESIUM HYDROXIDE
Application type ANDA
Application number 077355
Company PERRIGO R AND D
Dosage forms TABLET, CHEWABLE, ORAL
Strength 800MG;10MG;165MG
Marketing status Over-the-counter
Reference listed drug No
Latest submission status date Feb 6, 2008

At a glance

  • 1–9 Submissions
  • 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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