Details for New Drug Application (NDA): 020603

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NDA 020603 describes CHILDREN'S MOTRIN, which is a drug marketed by Kenvue Brands 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. Fourteen suppliers are listed for this compound. Additional details are available on the ibuprofen; pseudoephedrine hydrochloride profile page.

Summary for 020603

Tradename:	CHILDREN'S MOTRIN
Applicant:	Kenvue Brands
Ingredient:	ibuprofen
Patents:	0

Pharmacology for NDA: 020603

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 020603

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

Suppliers and Packaging for NDA: 020603

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHILDREN'S MOTRIN	ibuprofen	SUSPENSION/DROPS;ORAL	020603	NDA	Kenvue Brands LLC	50580-100	50580-100-18	1 BOTTLE in 1 CARTON (50580-100-18) / 15 mL in 1 BOTTLE
CHILDREN'S MOTRIN	ibuprofen	SUSPENSION/DROPS;ORAL	020603	NDA	Kenvue Brands LLC	50580-198	50580-198-50	1 BOTTLE in 1 CARTON (50580-198-50) / 30 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	SUSPENSION/DROPS;ORAL			Strength	40MG/ML
Approval Date:	Jun 10, 1996	TE:		RLD:	Yes

Expired US Patents for NDA 020603

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kenvue Brands	CHILDREN'S MOTRIN	ibuprofen	SUSPENSION/DROPS;ORAL	020603-001	Jun 10, 1996	5,374,659*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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