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Last Updated: December 4, 2023

Details for New Drug Application (NDA): 020516

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NDA 020516 describes CHILDREN'S MOTRIN, which is a drug marketed by J And J Consumer Inc and is included in four NDAs. It is available from one supplier. Additional details are available on the CHILDREN'S MOTRIN profile page.

The generic ingredient in CHILDREN'S MOTRIN is ibuprofen; pseudoephedrine hydrochloride. There are sixty-four drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the ibuprofen; pseudoephedrine hydrochloride profile page.

Summary for 020516

Tradename:	CHILDREN'S MOTRIN
Applicant:	J And J Consumer Inc
Ingredient:	ibuprofen
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020516

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 020516

Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 020516

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHILDREN'S MOTRIN	ibuprofen	SUSPENSION;ORAL	020516	NDA	Johnson & Johnson Consumer Inc.	50580-184	50580-184-01	1 BOTTLE, PLASTIC in 1 CARTON (50580-184-01) / 240 mL in 1 BOTTLE, PLASTIC
CHILDREN'S MOTRIN	ibuprofen	SUSPENSION;ORAL	020516	NDA	Johnson & Johnson Consumer Inc.	50580-184	50580-184-50	1 BOTTLE, PLASTIC in 1 CARTON (50580-184-50) / 120 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	SUSPENSION;ORAL			Strength	100MG/5ML
Approval Date:	Jun 16, 1995	TE:		RLD:	Yes

Expired US Patents for NDA 020516

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
J And J Consumer Inc	CHILDREN'S MOTRIN	ibuprofen	SUSPENSION;ORAL	020516-001	Jun 16, 1995	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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