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Generated: November 17, 2018

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Details for New Drug Application (NDA): 020812

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NDA 020812 describes PEDIATRIC ADVIL, which is a drug marketed by Pfizer 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 are sixty-four drug master file entries for this compound. Two hundred and sixty-five suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.
Summary for 020812
Tradename:PEDIATRIC ADVIL
Applicant:Pfizer
Ingredient:ibuprofen
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 020812
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PEDIATRIC ADVIL ibuprofen SUSPENSION/DROPS;ORAL 020812 NDA Pfizer Consumer Healthcare 0573-0191 0573-0191-20 1 BOTTLE, DROPPER in 1 CARTON (0573-0191-20) > 15 mL in 1 BOTTLE, DROPPER
PEDIATRIC ADVIL ibuprofen SUSPENSION/DROPS;ORAL 020812 NDA Pfizer Consumer Healthcare 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:OTCDosage:SUSPENSION/DROPS;ORALStrength100MG/2.5ML
Approval Date:Jan 30, 1998TE:RLD:Yes

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