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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 209471

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NDA 209471 describes COMBOGESIC, which is a drug marketed by Aft Pharms Us and Hikma and is included in two NDAs. It is available from three suppliers. There are nine patents protecting this drug. Additional details are available on the COMBOGESIC profile page.

The generic ingredient in COMBOGESIC is acetaminophen; ibuprofen sodium. There are sixty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the acetaminophen; ibuprofen sodium profile page.

Summary for 209471

Tradename:	COMBOGESIC
Applicant:	Aft Pharms Us
Ingredient:	acetaminophen; ibuprofen
Patents:	3

Pharmacology for NDA: 209471

Mechanism of Action	Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 209471

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
COMBOGESIC	acetaminophen; ibuprofen	TABLET;ORAL	209471	NDA	Hikma Pharmaceuticals USA Inc	0143-9432	0143-9432-27	250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0143-9432-27)
COMBOGESIC	acetaminophen; ibuprofen	TABLET;ORAL	209471	NDA	Preferred Pharmaceuticals Inc.	68788-4009	68788-4009-1	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-4009-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	325MG;97.5MG
Approval Date:	Mar 1, 2023	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Mar 1, 2026
Regulatory Exclusivity Use:	NEW PRODUCT
Patent:	⤷ Get Started Free	Patent Expiration:	Sep 22, 2025	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	A METHOD OF TREATING MILD TO MODERATE ACUTE PAIN IN ADULTS BY ADMINISTERING 975-1000 MG OF ACETAMINOPHEN AND 292.5-300 MG OF IBUPROFEN IN A SINGLE ADMINISTRATION
Patent:	⤷ Get Started Free	Patent Expiration:	Feb 27, 2039	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	A METHOD OF TREATING MILD TO MODERATE ACUTE PAIN IN ADULTS BY ADMINISTERING 975-1000 MG OF ACETAMINOPHEN AND 292.5-300 MG OF IBUPROFEN IN A SINGLE ADMINISTRATION

Expired US Patents for NDA 209471

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aft Pharms Us	COMBOGESIC	acetaminophen; ibuprofen	TABLET;ORAL	209471-001	Mar 1, 2023	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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