Drug application

PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM)

Drugs@FDA ANDA 216247 · DEXCEL

Key facts

Drug name PANTOPRAZOLE SODIUM
Active ingredients PANTOPRAZOLE SODIUM
Application type ANDA
Application number 216247
Company DEXCEL
Dosage forms FOR SUSPENSION, DELAYED RELEASE, ORAL
Strength EQ 40MG BASE
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Jun 16, 2023

At a glance

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

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