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BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
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Serving leading biopharmaceutical companies globally:

Chubb
US Army
Teva
Healthtrust
QuintilesIMS
Cerilliant
McKinsey
UBS
Fuji
Medtronic

Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091393

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NDA 091393 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, Mallinckrodt Inc, Nesher Pharms, Rhodes Pharms, Sun Pharm Inds Inc, Vintage Pharms, Barr Labs Inc, and Watson Labs, and is included in forty-four NDAs. It is available from forty-nine 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 091393

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 091393

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 091393

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET;ORAL 091393 ANDA KVK-TECH,INC 10702-008 10702-008-01 100 TABLET in 1 BOTTLE (10702-008-01)
OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET;ORAL 091393 ANDA KVK-TECH,INC 10702-008 10702-008-50 500 TABLET in 1 BOTTLE (10702-008-50)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Aug 31, 2009TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Aug 31, 2009TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Aug 31, 2009TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Chubb
Dow
QuintilesIMS
Farmers Insurance
Moodys
Harvard Business School
US Department of Justice
Colorcon
Daiichi Sankyo

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