FdaApplication
NDA 022275
Identifiers
- fda_app_no: NDA022275
Properties
| Property | Value |
|---|---|
| applicant_name | OTSUKA PHARMACEUTICAL CO LTD |
| application_type | NDA |
| approval_date | 2009-05-19 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| SAMSCA | TOLVAPTAN | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| SAMSCA | TOLVAPTAN | 30MG | TABLET;ORAL |
| SAMSCA | TOLVAPTAN | 15MG | TABLET;ORAL |
3 products