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Last Updated: March 5, 2024

Details for New Drug Application (NDA): 211733


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NDA 211733 describes ADVIL DUAL ACTION WITH ACETAMINOPHEN, which is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from two suppliers. Additional details are available on the ADVIL DUAL ACTION WITH ACETAMINOPHEN profile page.

The generic ingredient in ADVIL DUAL ACTION WITH ACETAMINOPHEN is acetaminophen; ibuprofen. There are sixty-six drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the acetaminophen; ibuprofen profile page.
Summary for 211733
Pharmacology for NDA: 211733
Mechanism of ActionCyclooxygenase Inhibitors
Suppliers and Packaging for NDA: 211733
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADVIL DUAL ACTION WITH ACETAMINOPHEN acetaminophen; ibuprofen TABLET;ORAL 211733 NDA Haleon US Holdings LLC 0573-0145 0573-0145-02 2 TABLET, FILM COATED in 1 POUCH (0573-0145-02)
ADVIL DUAL ACTION WITH ACETAMINOPHEN acetaminophen; ibuprofen TABLET;ORAL 211733 NDA Haleon US Holdings LLC 0573-0145 0573-0145-18 1 BOTTLE in 1 CARTON (0573-0145-18) / 18 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength250MG;125MG
Approval Date:Feb 28, 2020TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 28, 2023
Regulatory Exclusivity Use:NEW PRODUCT

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