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Last Updated: August 11, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 011707

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NDA 011707 describes OPANA, which is a drug marketed by Endo Pharms and is included in four NDAs. 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. Eight suppliers are listed for this compound. Additional details are available on the oxymorphone hydrochloride profile page.
Summary for 011707
Tradename:OPANA
Applicant:Endo Pharms
Ingredient:oxymorphone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 011707

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength1.5MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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