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.
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: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jun 21, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | DOSE MODIFICATION FOR RENAL IMPAIRMENT | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Nov 22, 2029 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jun 21, 2027 | Product 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 | 021610-006 | Feb 29, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| 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 | 021610-005 | Feb 29, 2008 | ⤷ 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 | 021610-005 | Feb 29, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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