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Serving hundreds of leading biopharmaceutical companies globally:

Dow
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Accenture
Medtronic
Moodys
US Department of Justice
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Cipla

Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040545

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NDA 040545 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 Co Inc, Mayne Pharma Inc, Mikart, Nesher Pharms, Novel Labs Inc, Rhodes Pharms, Sun Pharm Inds Inc, and Wes Pharma Inc, and is included in forty-four NDAs. It is available from forty-five 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 suppliers are listed for this compound. Additional details are available on the acetaminophen; oxycodone hydrochloride profile page.
Summary for 040545
Tradename:OXYCODONE AND ACETAMINOPHEN
Applicant:Specgx Llc
Ingredient:acetaminophen; oxycodone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040545
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 040545
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 040545 ANDA SpecGx LLC 0406-0522 N 0406-0522-01
OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 040545 ANDA SpecGx LLC 0406-0522 N 0406-0522-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;7.5MG
Approval Date:Jun 30, 2004TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;10MG
Approval Date:Jun 30, 2004TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Cantor Fitzgerald
Deloitte
Cipla
Federal Trade Commission
Daiichi Sankyo
Fuji
Fish and Richardson
Harvard Business School

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