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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 201803


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NDA 201803 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 201803
Tradename:ADVIL
Applicant:Haleon Us Holdings
Ingredient:ibuprofen sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 201803
Mechanism of ActionCyclooxygenase Inhibitors
Suppliers and Packaging for NDA: 201803
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADVIL ibuprofen sodium TABLET;ORAL 201803 NDA Haleon US Holdings LLC 0573-0133 0573-0133-01 3000 PACKET in 1 CASE (0573-0133-01) / 2 TABLET, COATED in 1 PACKET
ADVIL ibuprofen sodium TABLET;ORAL 201803 NDA Haleon US Holdings LLC 0573-0133 0573-0133-02 50 PACKET in 1 TRAY (0573-0133-02) / 2 TABLET, COATED in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrengthEQ 200MG BASE
Approval Date:Jun 12, 2012TE:RLD:Yes

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