Drug application

ESOMEPRAZOLE STRONTIUM (ESOMEPRAZOLE STRONTIUM)

Drugs@FDA NDA 202342 · BELCHER

Key facts

Drug name ESOMEPRAZOLE STRONTIUM
Active ingredients ESOMEPRAZOLE STRONTIUM
Application type NDA
Application number 202342
Company BELCHER
Dosage forms CAPSULE, DELAYED RELEASE, ORAL
Strength 24.65MG
Marketing status Discontinued
Reference listed drug Yes
Latest submission class Type 2 - New Active Ingredient
Latest submission status date Aug 6, 2013

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 1–9 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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