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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 206610

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NDA 206610 describes ACETAMINOPHEN, which is a drug marketed by Rising, Aspiro, B Braun Medical, Baxter Hlthcare Corp, Caplin, 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, 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, Lnk Intl Inc, Gavis Pharms, Wraser Pharms Llc, Boca Pharma Llc, and West-ward Pharm Corp, and is included in one hundred and forty-five NDAs. It is available from ninety-seven 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 206610

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

Medical Subject Heading (MeSH) Categories for 206610

Analgesics, Non-Narcotic
Antipyretics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER;INTRAVENOUS			Strength	1GM/VIAL
Approval Date:	Jan 15, 2021	TE:		RLD:	Yes

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