Drug application

NAPROXEN AND ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM, NAPROXEN)

Drugs@FDA ANDA 204470 · ACTAVIS LABS FL INC

Key facts

Drug name NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
Active ingredients ESOMEPRAZOLE MAGNESIUM, NAPROXEN
Application type ANDA
Application number 204470
Company ACTAVIS LABS FL INC
Dosage forms TABLET, DELAYED RELEASE, ORAL
Strength EQ 20MG BASE;375MG
Marketing status Discontinued
TE codes AB
Reference listed drug No
Latest submission status date Aug 24, 2022

At a glance

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