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Serving leading biopharmaceutical companies globally:

US Army
US Department of Justice
Queensland Health
Fish and Richardson
Medtronic
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Generated: October 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021011

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NDA 021011 describes ROXICODONE, which is a drug marketed by Mallinckrodt Inc and Roxane and is included in two NDAs. It is available from two suppliers. Additional details are available on the ROXICODONE profile page.

The generic ingredient in ROXICODONE is oxycodone hydrochloride. There are seventeen drug master file entries for this compound. Sixty suppliers are listed for this compound. Additional details are available on the oxycodone hydrochloride profile page.

Summary for NDA: 021011

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

Pharmacology for NDA: 021011

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 021011

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROXICODONE
oxycodone hydrochloride
TABLET;ORAL 021011 NDA STAT RX USA LLC 16590-913 16590-913-72 120 TABLET in 1 BOTTLE, PLASTIC (16590-913-72)
ROXICODONE
oxycodone hydrochloride
TABLET;ORAL 021011 NDA Mallinckrodt, Inc 23635-580 23635-580-10 100 TABLET in 1 BOTTLE, PLASTIC (23635-580-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Aug 31, 2000TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Aug 31, 2000TE:ABRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:May 15, 2009TE:ABRLD:Yes


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Daiichi Sankyo
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Harvard Business School
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Farmers Insurance

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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