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Serving leading biopharmaceutical companies globally:

AstraZeneca
Teva
Farmers Insurance
Medtronic
Fuji
Novartis
Healthtrust
Queensland Health
Colorcon
Covington

Generated: December 16, 2017

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, Mallinckrodt Inc, Alvogen Malta, Amneal Pharms, Amneal Pharms Ny, Ascent Pharms Inc, Aurolife Pharma Llc, Cerovene Inc, Lannett Holdings Inc, Mayne Pharma Inc, Mikart, Novel Labs Inc, Rhodes Pharms, and Sun Pharm Inds Inc, and is included in forty-one 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 040545

Tradename:1
Applicant:1
Ingredient:1
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 Mallinckrodt, Inc. 0406-0522 0406-0522-23 1 TABLET in 1 BLISTER PACK (0406-0522-23)
OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 040545 ANDA Mallinckrodt, Inc. 0406-0522 0406-0522-05 500 TABLET in 1 BOTTLE (0406-0522-05)

Summary for product number 001

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

Summary for product number 002

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


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Serving leading biopharmaceutical companies globally:

Queensland Health
Accenture
Boehringer Ingelheim
US Army
Merck
McKinsey
Mallinckrodt
Express Scripts
Cantor Fitzgerald
UBS

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