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Serving leading biopharmaceutical companies globally:

Queensland Health
Fish and Richardson
Farmers Insurance
US Department of Justice
Chubb
Healthtrust
UBS
Citi
Johnson and Johnson
Merck

Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021611

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NDA 021611 describes OPANA, which is a drug marketed by Endo Pharms and is included in four NDAs. It is available from five suppliers. There are ten patents protecting this drug and six Paragraph IV challenges. Additional details are available on the OPANA profile page.

The generic ingredient in OPANA is oxymorphone hydrochloride. There are nine drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the oxymorphone hydrochloride profile page.
Summary for 021611
Tradename:OPANA
Applicant:Endo Pharms
Ingredient:oxymorphone hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 021611
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 021611
Suppliers and Packaging for NDA: 021611
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OPANA oxymorphone hydrochloride TABLET;ORAL 021611 NDA Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC 35356-380 E 35356-380-30
OPANA oxymorphone hydrochloride TABLET;ORAL 021611 NDA Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC 35356-380 E 35356-380-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jun 22, 2006TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jun 22, 2006TE:ABRLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Moodys
QuintilesIMS
Fuji
AstraZeneca
US Department of Justice
Baxter
Cipla
Chubb

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