Drug application

NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUM)

Drugs@FDA ANDA 208499 · PERRIGO R AND D

Key facts

Drug name NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE
Active ingredients DIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUM
Application type ANDA
Application number 208499
Company PERRIGO R AND D
Dosage forms TABLET, ORAL
Strength 25MG;220MG
Marketing status Over-the-counter
Reference listed drug No
Latest submission status date May 10, 2019

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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