Drug application

OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM)

Drugs@FDA ANDA 210593 · SPIL

Key facts

Drug name OMEPRAZOLE MAGNESIUM
Active ingredients OMEPRAZOLE MAGNESIUM
Application type ANDA
Application number 210593
Company SPIL
Dosage forms CAPSULE, DELAYED RELEASE, ORAL
Strength EQ 20MG BASE
Marketing status Discontinued
Reference listed drug No
Latest submission status date Jul 20, 2018

At a glance

  • 1–9 Submissions
  • None 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

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