Details for New Drug Application (NDA): 021611
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NDA 021611 describes OPANA, which is a drug marketed by Endo Pharms and Endo Operations and is included in four NDAs. There are five 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.
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 |
Medical Subject Heading (MeSH) Categories for 021611
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jun 22, 2006 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jun 22, 2006 | TE: | RLD: | Yes | |||||
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