Orange Book product · Brand (NDA)

ADVIL DUAL ACTION WITH ACETAMINOPHEN

ACETAMINOPHEN; IBUPROFEN

Brand (NDA)NDA 211733OTC HALEON US HOLDINGS

Feb 28, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Feb 28, 2020
6 yr 5 mo ago
Today
Patent 11918693 expires
Listed drug product patent expiration.
Jul 09, 2041
in 15 yr 3 mo

Active ingredient

ACETAMINOPHEN; IBUPROFEN

Strength

250MG;125MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 211733

Product number

001

Marketing status

OTC

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11918693	Jul 09, 2041	in 15 yr 3 mo	Product