Last Updated: June 24, 2026

Details for New Drug Application (NDA): 216467

✉ Email this page to a colleague

« Back to Dashboard

NDA 216467 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-two 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 216467

Tradename:	ACETAMINOPHEN
Applicant:	Zydus Pharms
Ingredient:	acetaminophen
Patents:	0

Medical Subject Heading (MeSH) Categories for 216467

Analgesics, Non-Narcotic
Antipyretics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	1GM/100ML (10MG/ML)
Approval Date:	Oct 25, 2022	TE:		RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.