Details for New Drug Application (NDA): 201655
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The generic ingredient in OPANA ER is oxymorphone hydrochloride. There are nine drug master file entries for this compound. Ten 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 |
Patents: | 5 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 201655
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 5MG | ||||
Approval Date: | Dec 9, 2011 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Jul 10, 2029 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 8, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Try a Trial | Patent Expiration: | Sep 15, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 201655
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