FdaApplication
ANDA 079046
Identifiers
- fda_app_no: ANDA079046
Properties
| Property | Value |
|---|---|
| applicant_name | ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC |
| application_type | ANDA |
| approval_date | 2010-12-13 |
Products (7)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 5MG | TABLET, EXTENDED RELEASE;ORAL |
| OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 15MG | TABLET, EXTENDED RELEASE;ORAL |
| OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 40MG | TABLET, EXTENDED RELEASE;ORAL |
| OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL |
| OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 7.5MG | TABLET, EXTENDED RELEASE;ORAL |
| OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 30MG | TABLET, EXTENDED RELEASE;ORAL |
| OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 20MG | TABLET, EXTENDED RELEASE;ORAL |
7 products