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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 020589

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NDA 020589 describes CHILDREN'S ADVIL-FLAVORED, which is a drug marketed by Haleon Us Holdings and is included in one NDA. It is available from one supplier. Additional details are available on the CHILDREN'S ADVIL-FLAVORED profile page.

The generic ingredient in CHILDREN'S ADVIL-FLAVORED is ibuprofen. There are sixty-four drug master file entries for this compound. Two hundred and forty-six suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.

Summary for 020589

Tradename:	CHILDREN'S ADVIL-FLAVORED
Applicant:	Haleon Us Holdings
Ingredient:	ibuprofen
Patents:	0

Pharmacology for NDA: 020589

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 020589

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

Suppliers and Packaging for NDA: 020589

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHILDREN'S ADVIL	ibuprofen	SUSPENSION;ORAL	020589	NDA	Haleon US Holdings LLC	0573-0170	0573-0170-01	1 BOTTLE in 1 CARTON (0573-0170-01) / 30 mL in 1 BOTTLE
CHILDREN'S ADVIL	ibuprofen	SUSPENSION;ORAL	020589	NDA	Haleon US Holdings LLC	0573-0170	0573-0170-30	1 BOTTLE in 1 CARTON (0573-0170-30) / 120 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	SUSPENSION;ORAL			Strength	100MG/5ML
Approval Date:	Jun 27, 1996	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	SUSPENSION;ORAL			Strength	100MG/5ML
Approval Date:	Nov 7, 1997	TE:		RLD:	No

Expired US Patents for NDA 020589

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Haleon Us Holdings	CHILDREN'S ADVIL	ibuprofen	SUSPENSION;ORAL	020589-001	Jun 27, 1996	⤷ Get Started Free	⤷ Get Started Free
Haleon Us Holdings	CHILDREN'S ADVIL-FLAVORED	ibuprofen	SUSPENSION;ORAL	020589-002	Nov 7, 1997	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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