FdaApplication
NDA 213072
Identifiers
- fda_app_no: NDA213072
Properties
| Property | Value |
|---|---|
| applicant_name | ALTHERA PHARMACEUTICALS LLC |
| application_type | NDA |
| approval_date | 2021-03-23 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ROSZET | EZETIMIBE; ROSUVASTATIN CALCIUM | 10MG;EQ 20MG BASE | TABLET;ORAL |
| ROSZET | EZETIMIBE; ROSUVASTATIN CALCIUM | 10MG;EQ 40MG BASE | TABLET;ORAL |
| ROSZET | EZETIMIBE; ROSUVASTATIN CALCIUM | 10MG;EQ 5MG BASE | TABLET;ORAL |
| ROSZET | EZETIMIBE; ROSUVASTATIN CALCIUM | 10MG;EQ 10MG BASE | TABLET;ORAL |
4 products