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Last Updated: April 25, 2024

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. There is one patent protecting this drug. 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 thirty-four 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:	1
Formulation / Manufacturing:	see details

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
Patent:	⤷ Try a Trial	Patent Expiration:	May 25, 2024	Product Flag?	Y	Substance Flag?		Delist Request?

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	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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