Drug application

NAPROXEN SODIUM (NAPROXEN SODIUM)

Drugs@FDA ANDA 214463 · PATHEON SOFTGELS

Key facts

Drug name NAPROXEN SODIUM
Active ingredients NAPROXEN SODIUM
Application type ANDA
Application number 214463
Company PATHEON SOFTGELS
Dosage forms CAPSULE, ORAL
Strength EQ 200MG BASE
Marketing status Over-the-counter
Reference listed drug No
Latest submission status date Jan 10, 2023

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 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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