FdaApplication
ANDA 078483
Identifiers
- fda_app_no: ANDA078483
Properties
| Property | Value |
|---|---|
| applicant_name | SYNTHON PHARMACEUTICALS INC |
| application_type | ANDA |
| approval_date | 2011-04-12 |
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