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Serving leading biopharmaceutical companies globally:

UBS
Argus Health
QuintilesIMS
Cantor Fitzgerald
Chubb
US Army
Chinese Patent Office
Mallinckrodt
McKesson
Johnson and Johnson

Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040777

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NDA 040777 describes OXYCODONE AND ACETAMINOPHEN, which is a drug marketed by Actavis Elizabeth, Barr, Duramed Pharms Barr, Halsey, Mallinckrodt, Mutual Pharm, Vintage Pharms, Vintage Pharms Llc, Watson Labs, Specgx Llc, Abhai Llc, Alvogen Malta, Amneal Pharms, Amneal Pharms Ny, Ascent Pharms Inc, Aurolife Pharma Llc, Chemo Research Sl, Lannett Holdings Inc, Mayne Pharma Inc, Mikart, Nesher Pharms, Novel Labs Inc, Rhodes Pharms, and Sun Pharm Inds Inc, and is included in forty-three NDAs. It is available from forty-six suppliers. Additional details are available on the OXYCODONE AND ACETAMINOPHEN profile page.

The generic ingredient in OXYCODONE AND ACETAMINOPHEN is acetaminophen; oxycodone hydrochloride. There are sixty-six drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the acetaminophen; oxycodone hydrochloride profile page.
Summary for 040777
Tradename:OXYCODONE AND ACETAMINOPHEN
Applicant:Amneal Pharms
Ingredient:acetaminophen; oxycodone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040777
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 040777
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 040777 ANDA Blenheim Pharmacal, Inc. 10544-621 E 10544-621-50
OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 040777 ANDA Blenheim Pharmacal, Inc. 10544-621 E 10544-621-06

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;5MG
Approval Date:Nov 27, 2007TE:AARLD:No

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