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Last Updated: April 24, 2024

Details for New Drug Application (NDA): 018989

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NDA 018989 describes ADVIL, which is a drug marketed by Haleon Us Holdings and is included in eleven NDAs. It is available from four suppliers. There is one patent protecting this drug and three Paragraph IV challenges. Additional details are available on the ADVIL profile page.

The generic ingredient in ADVIL is diphenhydramine citrate; ibuprofen. There are twenty-three drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the diphenhydramine citrate; ibuprofen profile page.
Summary for 018989
Applicant:Haleon Us Holdings
Formulation / Manufacturing:see details
Pharmacology for NDA: 018989
Mechanism of ActionCyclooxygenase Inhibitors
Suppliers and Packaging for NDA: 018989
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADVIL ibuprofen TABLET;ORAL 018989 NDA Haleon US Holdings LLC 0573-0150 0573-0150-20 1 BOTTLE in 1 CARTON (0573-0150-20) / 24 TABLET, COATED in 1 BOTTLE
ADVIL ibuprofen TABLET;ORAL 018989 NDA Haleon US Holdings LLC 0573-0150 0573-0150-30 1 BOTTLE in 1 CARTON (0573-0150-30) / 50 TABLET, COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength200MG
Approval Date:May 18, 1984TE:RLD:Yes

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