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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 211544

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NDA 211544 describes ACETAMINOPHEN, which is a drug marketed by Rising, Aspiro, B Braun Medical, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Inforlife, Mylan, Sandoz, Wockhardt Bio Ag, Zydus Pharms, Able, Acino Prods, Perrigo New York, Taro, Aurobindo Pharma, Granules, Heritage Pharma, Marksans Pharma, Ohm Labs, Perrigo, Sun Pharm Inds Ltd, Teva, Actavis Mid Atlantic, Chartwell, Chartwell Molecular, Dava Pharms Inc, Genus Lifesciences, Pai Holdings, Pharmobedient, Strides Pharma, Am Therap, Amneal Pharms Ny, Ani Pharms, Aurolife Pharma Llc, Duramed Pharms Barr, Elite Labs Inc, Everylife, Fosun Pharma, Halsey, Hibrow Hlthcare, Kv Pharm, Lederle, Mikart, Mutual Pharm, Puracap Pharm, Purepac Pharm, Rhodes Pharms, Roxane, Specgx Llc, Strides Pharma Intl, Superpharm, Usl Pharma, Valeant Pharm Intl, Vitarine, Warner Chilcott, Watson Labs, Watson Labs Florida, Whiteworth Town Plsn, Cent Pharms, Aurobindo Pharma Ltd, Bionpharma, Dr Reddys, Glenmark Pharms Ltd, L Perrigo Co, Gavis Pharms, Wraser Pharms Llc, Boca Pharma Llc, and West-ward Pharm Corp, and is included in one hundred and forty-two NDAs. It is available from one hundred suppliers. There is one patent protecting this drug. Additional details are available on the ACETAMINOPHEN profile page.

The generic ingredient in ACETAMINOPHEN is acetaminophen; caffeine; dihydrocodeine bitartrate. 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; caffeine; dihydrocodeine bitartrate profile page.

Summary for 211544

Tradename:	ACETAMINOPHEN
Applicant:	Granules
Ingredient:	acetaminophen
Patents:	0

Medical Subject Heading (MeSH) Categories for 211544

Analgesics, Non-Narcotic
Antipyretics

Suppliers and Packaging for NDA: 211544

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACETAMINOPHEN	acetaminophen	TABLET, EXTENDED RELEASE;ORAL	211544	ANDA	Walgreens	0363-0892	0363-0892-04	20 TABLET in 1 BOTTLE (0363-0892-04)
ACETAMINOPHEN	acetaminophen	TABLET, EXTENDED RELEASE;ORAL	211544	ANDA	WALGREENS	0363-9992	0363-9992-10	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0363-9992-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	650MG
Approval Date:	Apr 16, 2019	TE:		RLD:	No

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