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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Chinese Patent Office
Healthtrust
Moodys
Harvard Business School
Citi
AstraZeneca
QuintilesIMS
Mallinckrodt

Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091313

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NDA 091313 describes OXYCODONE HYDROCHLORIDE, which is a drug marketed by Ani Pharms Inc, Avanthi Inc, Genus Lifesciences, Lannett Co Inc, Mayne Pharma Inc, Novel Labs Inc, Abhai Llc, Ascent Pharms Inc, Hi-tech Pharmacal, Pharm Assoc, Specgx Llc, Vistapharm, Wes Pharma Inc, West-ward Pharms Int, Wockhardt Bio Ag, Actavis Elizabeth, Alvogen Malta, Amneal Pharms, Aurolife Pharma Llc, Epic Pharma Llc, Ken Lifescience, Nesher Pharms, Rhodes Pharms, Sun Pharm Inds Inc, Vintage Pharms, Barr Labs Inc, and Watson Labs, and is included in forty-five NDAs. It is available from forty-eight suppliers. Additional details are available on the OXYCODONE HYDROCHLORIDE profile page.

The generic ingredient in OXYCODONE HYDROCHLORIDE is ibuprofen; oxycodone hydrochloride. There are sixty-four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ibuprofen; oxycodone hydrochloride profile page.
Summary for 091313
Tradename:OXYCODONE HYDROCHLORIDE
Applicant:Mayne Pharma Inc
Ingredient:oxycodone hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 091313
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 091313
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET;ORAL 091313 ANDA Mylan Pharmaceuticals Inc. 0378-6112 N 0378-6112-01
OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET;ORAL 091313 ANDA H.J. Harkins Company, Inc. 52959-130 E 52959-130-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Feb 18, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Feb 18, 2011TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Feb 18, 2011TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Deloitte
US Army
McKesson
QuintilesIMS
Citi
Express Scripts
Daiichi Sankyo
AstraZeneca

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