FdaApplication
NDA 021412
Identifiers
- fda_app_no: NDA021412
Properties
| Property | Value |
|---|---|
| applicant_name | BIOVAIL LABORATORIES INTERNATIONAL SRL |
| application_type | NDA |
| approval_date | 2007-04-25 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| TOVALT ODT | ZOLPIDEM TARTRATE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING;ORAL |
| TOVALT ODT | ZOLPIDEM TARTRATE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING;ORAL |
2 products