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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
QuintilesIMS
Citi
AstraZeneca
Daiichi Sankyo
Queensland Health
US Department of Justice
Healthtrust
Cipla

Generated: June 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201278

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NDA 201278 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-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 201278
Tradename:OXYCODONE AND ACETAMINOPHEN
Applicant:Rhodes Pharms
Ingredient:acetaminophen; oxycodone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 201278
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 201278
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 201278 ANDA Rhodes Pharmaceuticals L.P. 42858-102 N 42858-102-01
OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 201278 ANDA Rhodes Pharmaceuticals L.P. 42858-102 N 42858-102-50

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;5MG
Approval Date:Aug 28, 2014TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;7.5MG
Approval Date:Aug 28, 2014TE:AARLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;10MG
Approval Date:Aug 28, 2014TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Covington
Argus Health
Citi
Julphar
Fuji
US Department of Justice
Johnson and Johnson
Boehringer Ingelheim

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