Drug application

PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER (FAMOTIDINE)

Drugs@FDA NDA 020249 · MERCK SHARP DOHME

Key facts

Drug name PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER
Active ingredients FAMOTIDINE
Application type NDA
Application number 020249
Company MERCK SHARP DOHME
Dosage forms INJECTABLE, INJECTION
Strength 0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing status Discontinued
Reference listed drug Yes
Latest submission class Type 3 - New Dosage Form
Latest submission status date Feb 18, 1994

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • None Therapeutic equivalents

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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