FdaApplication
ANDA 208850
Identifiers
- fda_app_no: ANDA208850
Properties
| Property | Value |
|---|---|
| applicant_name | AMNEAL PHARMACEUTICALS CO GMBH |
| application_type | ANDA |
| approval_date | 2018-10-16 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL |
| ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET;ORAL |
4 products