Details for New Drug Application (NDA): 214836

NDA 214836 describes ACETAMINOPHEN AND IBUPROFEN, which is a drug marketed by Aurobindo Pharma Ltd, Bionpharma, Dr Reddys, Glenmark Pharms Ltd, Granules, L Perrigo Co, and Marksans Pharma, and is included in seven NDAs. It is available from thirty-five suppliers. Additional details are available on the ACETAMINOPHEN AND IBUPROFEN profile page.

The generic ingredient in ACETAMINOPHEN AND IBUPROFEN is acetaminophen; ibuprofen. There are sixty-six drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the acetaminophen; ibuprofen profile page.

Summary for 214836

Tradename:	ACETAMINOPHEN AND IBUPROFEN
Applicant:	L Perrigo Co
Ingredient:	acetaminophen; ibuprofen
Patents:	0

Pharmacology for NDA: 214836

Mechanism of Action

Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 214836

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACETAMINOPHEN AND IBUPROFEN	acetaminophen; ibuprofen	TABLET;ORAL	214836	ANDA	L. Perrigo Company	0113-5299	0113-5299-16	1 BOTTLE in 1 CARTON (0113-5299-16) / 144 TABLET, FILM COATED in 1 BOTTLE
ACETAMINOPHEN AND IBUPROFEN	acetaminophen; ibuprofen	TABLET;ORAL	214836	ANDA	L. Perrigo Company	0113-5299	0113-5299-23	1 BOTTLE in 1 CARTON (0113-5299-23) / 72 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	250MG;125MG
Approval Date:	Feb 28, 2023	TE:		RLD:	No

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