FdaApplication
NDA 204447
Identifiers
- fda_app_no: NDA204447
Properties
| Property | Value |
|---|---|
| applicant_name | TAKEDA PHARMACEUTICALS USA INC |
| application_type | NDA |
| approval_date | 2013-09-30 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| TRINTELLIX | VORTIOXETINE HYDROBROMIDE | EQ 10MG BASE | TABLET;ORAL |
| TRINTELLIX | VORTIOXETINE HYDROBROMIDE | EQ 5MG BASE | TABLET;ORAL |
| TRINTELLIX | VORTIOXETINE HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL |
| TRINTELLIX | VORTIOXETINE HYDROBROMIDE | EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
4 products