ibuprofen; pseudoephedrine HCl

Phase 2

Johnson & Johnson (JNJ)

Phase 2

Development Phase

Upcoming Catalysts

Historical Events

Regulatory Approvals

No Catalysts Found

No catalyst events have been recorded for this drug yet.

Competitive Landscape

1 competitor in Enuresis

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Drug Information

Target Indication

Enuresis

Clinical Trial

NCT00240812

Last updated: 12/4/2025

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Source: FDA Orange Book

Regulatory Approvals

EMAPending

Ibuprofen/Diphenhydramine Hydrochloride Wyeth

View on EMA

EMA2/16/2024

Ibuprofen Gen.Orph

Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age

View on EMA

EMA7/28/2004

Pedea

Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age.

View on EMA

Drug Science

Mechanism of action & safety profile

Developer

JNJ

Johnson & Johnson

Pharmaceutical Preparations•North America•NYSE

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