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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 071011

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NDA 071011 describes ACETAMINOPHEN, which is a drug marketed by Rising, Aspiro, B Braun Medical Inc, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, 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, Strides Pharma, Am Therap, Amneal Pharms Ny, Aurolife Pharma Llc, Duramed Pharms Barr, Elite Labs Inc, Everylife, Fosun Pharma, Halsey, Kv Pharm, Lederle, Mikart, Mutual Pharm, Nostrum Labs Inc, Puracap Pharm, Purepac Pharm, Rhodes Pharms, Roxane, Specgx Llc, Superpharm, Usl Pharma, Valeant Pharm Intl, Vitarine, Warner Chilcott, Watson Labs, Watson Labs Florida, Wes Pharma Inc, Whiteworth Town Plsn, Cent Pharms, Aurobindo Pharma Ltd, Bionpharma, Dr Reddys, Glenmark Pharms Ltd, L Perrigo Co, Gavis Pharms, Larken Labs Inc, Wraser Pharms Llc, Boca Pharma Llc, and West-ward Pharm Corp, and is included in one hundred and forty NDAs. It is available from ninety-four 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 071011

Tradename:	ACETAMINOPHEN
Applicant:	Acino Prods
Ingredient:	acetaminophen
Patents:	0

Medical Subject Heading (MeSH) Categories for 071011

Analgesics, Non-Narcotic
Antipyretics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUPPOSITORY;RECTAL			Strength	650MG
Approval Date:	May 12, 1987	TE:		RLD:	No

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