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Last Updated: June 23, 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-five suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.
Summary for 020589
Applicant:Haleon Us Holdings
Formulation / Manufacturing:see details
Pharmacology for NDA: 020589
Mechanism of ActionCyclooxygenase 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:OTCDosage:SUSPENSION;ORALStrength100MG/5ML
Approval Date:Jun 27, 1996TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:SUSPENSION;ORALStrength100MG/5ML
Approval Date:Nov 7, 1997TE:RLD:No
Patent:⤷  Sign UpPatent Expiration:May 25, 2024Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 020589

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 ⤷  Sign Up ⤷  Sign Up
Haleon Us Holdings CHILDREN'S ADVIL-FLAVORED ibuprofen SUSPENSION;ORAL 020589-002 Nov 7, 1997 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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