FdaApplication
NDA 200153
Identifiers
- fda_app_no: NDA200153
Properties
| Property | Value |
|---|---|
| applicant_name | ORGANON LLC A SUB OF ORGANON AND CO |
| application_type | NDA |
| approval_date | 2013-05-03 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| LIPTRUZET | ATORVASTATIN CALCIUM; EZETIMIBE | EQ 40MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| LIPTRUZET | ATORVASTATIN CALCIUM; EZETIMIBE | EQ 10MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| LIPTRUZET | ATORVASTATIN CALCIUM; EZETIMIBE | EQ 20MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| LIPTRUZET | ATORVASTATIN CALCIUM; EZETIMIBE | EQ 80MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
4 products