FdaApplication
NDA 021610
Identifiers
- fda_app_no: NDA021610
Properties
| Property | Value |
|---|---|
| applicant_name | ENDO OPERATIONS LTD |
| application_type | NDA |
| approval_date | 2006-06-22 |
Products (7)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| OPANA ER | OXYMORPHONE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
| OPANA ER | OXYMORPHONE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
| OPANA ER | OXYMORPHONE HYDROCHLORIDE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
| OPANA ER | OXYMORPHONE HYDROCHLORIDE | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
| OPANA ER | OXYMORPHONE HYDROCHLORIDE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
| OPANA ER | OXYMORPHONE HYDROCHLORIDE | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
| OPANA ER | OXYMORPHONE HYDROCHLORIDE | 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL |
7 products