FdaApplication
ANDA 212750
Identifiers
- fda_app_no: ANDA212750
Properties
| Property | Value |
|---|---|
| applicant_name | GRANULES PHARMACEUTICALS INC |
| application_type | ANDA |
| approval_date | 2021-10-14 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DOFETILIDE | DOFETILIDE | 0.125MG | CAPSULE;ORAL |
| DOFETILIDE | DOFETILIDE | 0.25MG | CAPSULE;ORAL |
| DOFETILIDE | DOFETILIDE | 0.5MG | CAPSULE;ORAL |
3 products