NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE

Post-LOE

diphenhydramine hydrochloride; naproxen sodium

Macleods Pharms

ANDAORALTABLET

Approved

Aug 2019

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

2/8 — Basic

Drug data last refreshed 4h ago

Mechanism of Action

Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.

Indications

Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.

Clinical Trials (3)

NCT03424135Phase 1Completed

A Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects Under Fed Conditions

Started Mar 2018

60 enrolled

Clinical Pharmacology

NCT03396250Phase 1Completed

A Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects

Started Feb 2018

36 enrolled

Pain

NCT01666678Phase 1Completed

Compare Pharmacokinetic (PK) Profiles of Naproxen Sodium, Diphenhydramine Hydrochloride, and Naproxen Sodium and Diphenhydramine Hydrochloride Combination

Started Jan 2012

32 enrolled

Therapeutic Equivalence

Company

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.