FdaApplication
NDA 022107
Identifiers
- fda_app_no: NDA022107
Properties
| Property | Value |
|---|---|
| applicant_name | NODEN PHARMA DAC |
| application_type | NDA |
| approval_date | 2008-01-18 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| TEKTURNA HCT | ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE | EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| TEKTURNA HCT | ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE | EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| TEKTURNA HCT | ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE | EQ 300MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| TEKTURNA HCT | ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE | EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
4 products