Drug application

NAPROXEN SODIUM (NAPROXEN SODIUM)

Drugs@FDA ANDA 079096 · AMNEAL PHARMS NY

Key facts

Drug name NAPROXEN SODIUM
Active ingredients NAPROXEN SODIUM
Application type ANDA
Application number 079096
Company AMNEAL PHARMS NY
Dosage forms TABLET, ORAL
Strength 220MG
Marketing status Over-the-counter
Reference listed drug No
Latest submission status date Dec 16, 2008

At a glance

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