Details for New Drug Application (NDA): 211695

NDA 211695 describes ACETAMINOPHEN, ASPIRIN AND CAFFEINE, which is a drug marketed by Aurobindo Pharma Ltd, Granules, and Perrigo, and is included in three NDAs. It is available from thirty-nine suppliers. Additional details are available on the ACETAMINOPHEN, ASPIRIN AND CAFFEINE profile page.

The generic ingredient in ACETAMINOPHEN, ASPIRIN AND CAFFEINE is acetaminophen; aspirin; caffeine. There are sixty-six drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the acetaminophen; aspirin; caffeine profile page.

Summary for 211695

Tradename:	ACETAMINOPHEN, ASPIRIN AND CAFFEINE
Applicant:	Aurobindo Pharma Ltd
Ingredient:	acetaminophen; aspirin; caffeine
Patents:	0

Pharmacology for NDA: 211695

Mechanism of Action	Cyclooxygenase Inhibitors
Physiological Effect	Central Nervous System Stimulation Decreased Platelet Aggregation Decreased Prostaglandin Production

Suppliers and Packaging for NDA: 211695

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACETAMINOPHEN, ASPIRIN AND CAFFEINE	acetaminophen; aspirin; caffeine	TABLET;ORAL	211695	ANDA	Better Living Brands, LLC	21130-074	21130-074-07	1 BOTTLE in 1 CARTON (21130-074-07) / 24 TABLET, FILM COATED in 1 BOTTLE
ACETAMINOPHEN, ASPIRIN AND CAFFEINE	acetaminophen; aspirin; caffeine	TABLET;ORAL	211695	ANDA	Better Living Brands, LLC	21130-074	21130-074-14	1 BOTTLE in 1 CARTON (21130-074-14) / 50 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	250MG;250MG;65MG
Approval Date:	Feb 2, 2022	TE:		RLD:	No

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