Drug application

PROTONIX (PANTOPRAZOLE SODIUM)

Drugs@FDA NDA 022020 · WYETH PHARMS

Key facts

Drug name PROTONIX
Active ingredients PANTOPRAZOLE SODIUM
Application type NDA
Application number 022020
Company WYETH PHARMS
Dosage forms FOR SUSPENSION, DELAYED RELEASE, ORAL
Strength EQ 40MG BASE
Marketing status Prescription
TE codes AB
Reference listed drug Yes
Latest submission class Type 3 - New Dosage Form
Latest submission status date Nov 14, 2007

At a glance

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