FdaApplication
ANDA 078179
Identifiers
- fda_app_no: ANDA078179
Properties
| Property | Value |
|---|---|
| applicant_name | ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC |
| application_type | ANDA |
| approval_date | 2010-10-13 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE;ORAL |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE;ORAL |
2 products