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Last Updated: July 11, 2020

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Details for New Drug Application (NDA): 201655

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NDA 201655 describes OPANA ER, which is a drug marketed by Endo Pharms and is included in two NDAs. There are ten 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 201655
Tradename:OPANA ER
Applicant:Endo Pharms
Ingredient:oxymorphone hydrochloride
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 201655

Profile for product number 001

Approval Date:Dec 9, 2011TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jul 10, 2029Product Flag?Substance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Nov 20, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Aug 8, 2024Product Flag?YSubstance Flag?Delist Request?

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