IBUPROFEN AND DIPHENHYDRAMINE CITRATE

Post-LOE

ibuprofen and diphenhydramine citrate

Aurobindo Pharma

ANDAORALTABLET

Approved

May 2022

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

IBUPROFEN AND DIPHENHYDRAMINE CITRATE (ibuprofen and diphenhydramine citrate) by Aurobindo Pharma is cyclooxygenase inhibitors [moa]. Approved for nonsteroidal anti-inflammatory drug [epc]. First approved in 2022.

Drug data last refreshed 19h ago

Mechanism of Action

Cyclooxygenase Inhibitors

Pharmacologic Class:

Nonsteroidal Anti-inflammatory Drug

Indications

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

Clinical Trials (2)

NCT01053338Phase 1Completed

Bioequivalence Study of Dr.Reddy's Ibuprofen and Diphenhydramine Citrate 200 mg/38 mg Caplets Under Fed Condition

Started Apr 2008

40 enrolled

Healthy

NCT01053208Phase 1Completed

Bioequivalence Study of Dr.Reddy's Ibuprofen and Diphenhydramine Citrate 200 mg/38 mg Caplets Under Fasting Condition

Started Apr 2008

40 enrolled

Healthy

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.