Drug application

ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)

Drugs@FDA ANDA 213486 · GRAVITI PHARMS

Key facts

Drug name ESOMEPRAZOLE MAGNESIUM
Active ingredients ESOMEPRAZOLE MAGNESIUM
Application type ANDA
Application number 213486
Company GRAVITI PHARMS
Dosage forms CAPSULE, DELAYED REL PELLETS, ORAL
Strength EQ 20MG BASE
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Mar 19, 2021

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

Browse all Drugs@FDA applications