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Serving leading biopharmaceutical companies globally:

Novartis
Queensland Health
Cipla
QuintilesIMS
Daiichi Sankyo
Julphar
Teva
Harvard Business School
Colorcon
Fuji

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 007337

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NDA 007337 describes PERCODAN-DEMI, which is a drug marketed by Endo Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the PERCODAN-DEMI profile page.

The generic ingredient in PERCODAN-DEMI is aspirin; oxycodone hydrochloride; oxycodone terephthalate. There are twenty-one drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the aspirin; oxycodone hydrochloride; oxycodone terephthalate profile page.
Summary for 007337
Tradename:PERCODAN-DEMI
Applicant:Endo Pharms
Ingredient:aspirin; oxycodone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 007337
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PERCODAN aspirin; oxycodone hydrochloride; oxycodone terephthalate TABLET;ORAL 007337 NDA AUTHORIZED GENERIC STAT RX USA LLC 16590-947 16590-947-30 30 TABLET in 1 BOTTLE (16590-947-30)
PERCODAN aspirin; oxycodone hydrochloride; oxycodone terephthalate TABLET;ORAL 007337 NDA AUTHORIZED GENERIC STAT RX USA LLC 16590-947 16590-947-60 60 TABLET in 1 BOTTLE (16590-947-60)

Profile for product number 005

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength325MG;2.25MG;0.19MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 006

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength325MG;4.5MG;0.38MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 007

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;4.8355MG
Approval Date:Aug 5, 2005TE:AARLD:Yes

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Chinese Patent Office
Deloitte
Daiichi Sankyo
Argus Health
Mallinckrodt
Accenture
Farmers Insurance
Cipla

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