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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 202605

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NDA 202605 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 202605

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

Medical Subject Heading (MeSH) Categories for 202605

Analgesics, Non-Narcotic
Antipyretics

Suppliers and Packaging for NDA: 202605

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACETAMINOPHEN	acetaminophen	SOLUTION;INTRAVENOUS	202605	ANDA	Hikma Pharmaceuticals USA Inc.	24201-100	24201-100-24	24 VIAL, GLASS in 1 CARTON (24201-100-24) / 100 mL in 1 VIAL, GLASS
ACETAMINOPHEN	acetaminophen	SOLUTION;INTRAVENOUS	202605	ANDA	Hikma Pharmaceuticals USA Inc.	24201-110	24201-110-24	24 VIAL, GLASS in 1 CARTON (24201-110-24) / 100 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	1GM/100ML (10MG/ML)
Approval Date:	Jun 13, 2016	TE:	AP1	RLD:	No

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