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Last Updated: July 5, 2020

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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 one supplier. 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. Nine 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
Formulation / Manufacturing:see details
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 AUTHORIZED GENERIC Par Pharmaceutical 60951-794 60951-794-70 100 TABLET in 1 BOTTLE (60951-794-70)
OPANA oxymorphone hydrochloride TABLET;ORAL 021611 NDA AUTHORIZED GENERIC Par Pharmaceutical 60951-795 60951-795-70 100 TABLET in 1 BOTTLE (60951-795-70)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG
Approval Date:Jun 22, 2006TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 25, 2022
Regulatory Exclusivity Use:ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG
Approval Date:Jun 22, 2006TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 25, 2022
Regulatory Exclusivity Use:ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION

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Serving leading biopharmaceutical companies globally:

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