FdaApplication
ANDA 078707
Identifiers
- fda_app_no: ANDA078707
Properties
| Property | Value |
|---|---|
| applicant_name | RENATA PLC |
| application_type | ANDA |
| approval_date | 2008-12-29 |
Products (6)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| RISPERIDONE | RISPERIDONE | 0.5MG | TABLET;ORAL |
| RISPERIDONE | RISPERIDONE | 2MG | TABLET;ORAL |
| RISPERIDONE | RISPERIDONE | 0.25MG | TABLET;ORAL |
| RISPERIDONE | RISPERIDONE | 1MG | TABLET;ORAL |
| RISPERIDONE | RISPERIDONE | 4MG | TABLET;ORAL |
| RISPERIDONE | RISPERIDONE | 3MG | TABLET;ORAL |
6 products