Drug application

PEPCID COMPLETE (CALCIUM CARBONATE, FAMOTIDINE, MAGNESIUM HYDROXIDE)

Drugs@FDA NDA 020958 · KENVUE BRANDS

Key facts

Drug name PEPCID COMPLETE
Active ingredients CALCIUM CARBONATE, FAMOTIDINE, MAGNESIUM HYDROXIDE
Application type NDA
Application number 020958
Company KENVUE BRANDS
Dosage forms TABLET, CHEWABLE, ORAL
Strength 800MG;10MG;165MG
Marketing status Over-the-counter
Reference listed drug Yes
Latest submission class Type 4 - New Combination
Latest submission status date Oct 16, 2000

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 10–99 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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