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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
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Julphar
Healthtrust
Teva
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Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090659

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NDA 090659 describes OXYCODONE HYDROCHLORIDE, which is a drug marketed by Ani Pharms Inc, Avanthi Inc, Lannett Holdings Inc, Lehigh Valley, Mayne Pharma Inc, Novel Labs Inc, Abhai Llc, Ascent Pharms Inc, Hi-tech Pharmacal, Pharm Assoc, 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, Specgx Llc, Sun Pharm Inds Inc, Vintage Pharms, Barr Labs Inc, and Watson Labs, and is included in forty-four NDAs. It is available from forty-two 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 090659
Tradename:OXYCODONE HYDROCHLORIDE
Applicant:Sun Pharm Inds Inc
Ingredient:oxycodone hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 090659
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 090659
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET;ORAL 090659 ANDA PD-Rx Pharmaceuticals, Inc. 55289-891 N 55289-891-30
OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET;ORAL 090659 ANDA PD-Rx Pharmaceuticals, Inc. 55289-891 N 55289-891-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Apr 10, 2009TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Apr 10, 2009TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Apr 10, 2009TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Cipla
Mallinckrodt
Covington
US Department of Justice
Fish and Richardson
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Boehringer Ingelheim
Chinese Patent Office

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