Orange Book product · Brand (NDA)

COMBOGESIC

ACETAMINOPHEN; IBUPROFEN

Brand (NDA)NDA 209471RX AFT PHARMS US

Mar 01, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Mar 01, 2023
3 yr 4 mo ago
Exclusivity ends · NP
New product exclusivity (3 years)
Mar 01, 2026
4 mo ago
Today
Patent 11197830 expires
Listed drug product patent expiration.
Feb 27, 2039
in 12 yr 11 mo
Patent 11534407 expires
Listed drug product patent expiration.
Feb 27, 2039
in 12 yr 11 mo

Active ingredient

ACETAMINOPHEN; IBUPROFEN

Strength

325MG;97.5MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 209471

Product number

001

Marketing status

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
11197830	Feb 27, 2039	in 12 yr 11 mo	ProductU-3553
11534407	Feb 27, 2039	in 12 yr 11 mo	ProductU-3553