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Last Updated: November 7, 2024

Details for New Drug Application (NDA): 021610


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NDA 021610 describes OPANA ER, which is a drug marketed by Endo Operations and Endo Pharms and is included in two NDAs. There are five patents protecting this drug and six Paragraph IV challenges. Additional details are available on the OPANA ER profile page.

The generic ingredient in OPANA ER 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 021610
Tradename:OPANA ER
Applicant:Endo Operations
Ingredient:oxymorphone hydrochloride
Patents:2
Medical Subject Heading (MeSH) Categories for 021610

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jun 22, 2006TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jun 21, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:DOSE MODIFICATION FOR RENAL IMPAIRMENT
Patent:⤷  Sign UpPatent Expiration:Nov 22, 2029Product Flag?Substance Flag?YDelist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jun 22, 2006TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jun 21, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:DOSE MODIFICATION FOR RENAL IMPAIRMENT

Expired US Patents for NDA 021610

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Endo Operations OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-003 Jun 22, 2006 ⤷  Sign Up ⤷  Sign Up
Endo Operations OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-004 Jun 22, 2006 ⤷  Sign Up ⤷  Sign Up
Endo Operations OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-002 Jun 22, 2006 ⤷  Sign Up ⤷  Sign Up
Endo Operations OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-007 Feb 29, 2008 ⤷  Sign Up ⤷  Sign Up
Endo Operations OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-007 Feb 29, 2008 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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