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Last Updated: June 25, 2021

DrugPatentWatch Database Preview

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. Two suppliers are listed for this compound. Additional details are available on the acetaminophen; ibuprofen profile page.
Summary for 211733
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 211733
Generic Entry Date for 211733*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC 0573-0147 0573-0147-18 1 BOTTLE in 1 CARTON (0573-0147-18) > 18 TABLET, FILM COATED in 1 BOTTLE
ADVIL DUAL ACTION WITH ACETAMINOPHEN acetaminophen; ibuprofen TABLET;ORAL 211733 NDA GlaxoSmithKline Consumer Healthcare Holdings (US) LLC 0573-0147 0573-0147-36 1 BOTTLE in 1 CARTON (0573-0147-36) > 36 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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