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Last Updated: March 28, 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, ACI, Actavis Mid Atlantic, Akorn, Chartwell, Chartwell Molecular, Dava Pharms Inc, Genus Lifesciences, 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, Strides Pharma, Superpharm, Usl Pharma, Valeant Pharm Intl, Vitarine, Warner Chilcott, Watson Labs, Watson Labs Florida, Wes Pharma Inc, Whiteworth Town Plsn, Cent Pharms, Bionpharma, L Perrigo Co, Gavis Pharms, Aurobindo Pharma Ltd, Larken Labs Inc, Wraser Pharms Llc, Boca Pharma Llc, and West-ward Pharm Corp, and is included in one hundred and thirty-seven NDAs. It is available from ninety-one 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
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 071011

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SUPPOSITORY;RECTALStrength650MG
Approval Date:May 12, 1987TE:RLD:No

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