Last Updated: September 23, 2026

Details for New Drug Application (NDA): 020812


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NDA 020812 describes PEDIATRIC ADVIL, 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 PEDIATRIC ADVIL profile page.

The generic ingredient in PEDIATRIC ADVIL is ibuprofen. There is one drug master file entry for this compound. Two hundred and fifty suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.
Summary for 020812
Tradename:PEDIATRIC ADVIL
Applicant:Haleon Us Holdings
Ingredient:ibuprofen
Patents:0
Pharmacology for NDA: 020812
Mechanism of ActionCyclooxygenase Inhibitors
Medical Subject Heading (MeSH) Categories for 020812
Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors
Suppliers and Packaging for NDA: 020812
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INFANT'S ADVIL ibuprofen SUSPENSION/DROPS;ORAL 020812 NDA Haleon US Holdings LLC 0573-0191 0573-0191-20 1 BOTTLE, DROPPER in 1 CARTON (0573-0191-20) / 15 mL in 1 BOTTLE, DROPPER
INFANT'S ADVIL ibuprofen SUSPENSION/DROPS;ORAL 020812 NDA Haleon US Holdings LLC 0573-0191 0573-0191-22 1 BOTTLE, DROPPER in 1 CARTON (0573-0191-22) / 15 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SUSPENSION/DROPS;ORALStrength100MG/2.5ML
Approval Date:Jan 30, 1998TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:SUSPENSION/DROPS;ORALStrength50MG/1.25ML
Approval Date:Jan 12, 2000TE:RLD:Yes

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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