FdaApplication
NDA 021611
Identifiers
- fda_app_no: NDA021611
Properties
| Property | Value |
|---|---|
| applicant_name | ENDO PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 2006-06-22 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| OPANA | OXYMORPHONE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| OPANA | OXYMORPHONE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
2 products