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Details for New Drug Application (NDA): 073107

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NDA 073107 describes ACETAMINOPHEN, which is a drug marketed by Ohm Labs, Paddock Llc, Sun Pharm Inds Ltd, Able, Perrigo New York, Roxane, Aurobindo Pharma Ltd, Taro Pharms North, Sandoz Inc, Fresenius Kabi Usa, Perrigo, Aurolife Pharma Llc, Vintage, Wockhardt, Warner Chilcott, Whiteworth Town Plsn, Pharm Assoc, Everylife, Sandoz, Hi Tech Pharma, Mallinckrodt Inc, Usl Pharma, Duramed Pharms Barr, Teva, Vintage Pharms, Mikart, Lederle, Watson Labs Florida, Halsey, Mutual Pharm, Superpharm, Actavis Mid Atlantic, Puracap Pharm, Kv Pharm, Frontida Biopharm, Watson Labs, Vitarine, Am Therap, Amneal Pharms Ny, Purepac Pharm, Valeant Pharm Intl, Dava Pharms Inc, Cent Pharms, Gavis Pharms, Larken Labs Inc, Boca Pharma Llc, West-ward Pharm Corp, and Wraser Pharms Llc, and is included in one hundred and twenty NDAs. It is available from sixty-five suppliers. Additional details are available on the ACETAMINOPHEN profile page.

The generic ingredient in ACETAMINOPHEN is acetaminophen; caffeine; dihydrocodeine bitartrate. There are sixty-five drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the acetaminophen; caffeine; dihydrocodeine bitartrate profile page.

Summary for NDA: 073107

Tradename:
ACETAMINOPHEN
Applicant:
Able
Ingredient:
acetaminophen
Patents:0
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SUPPOSITORY;RECTALStrength325MG
Approval Date:Feb 27, 1995TE:RLD:No


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