Drug application

NAPROXEN SODIUM (NAPROXEN SODIUM)

Drugs@FDA ANDA 078432 · AMNEAL PHARMS NY

Key facts

Drug name NAPROXEN SODIUM
Active ingredients NAPROXEN SODIUM
Application type ANDA
Application number 078432
Company AMNEAL PHARMS NY
Dosage forms TABLET, ORAL
Strength EQ 250MG BASE
Marketing status Discontinued
TE codes AB
Reference listed drug No
Latest submission status date Apr 25, 2007

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents
  • No FDA letters on file
  • No FDA reviews on file

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 · Source date:

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