FdaApplication
ANDA 203490
Identifiers
- fda_app_no: ANDA203490
Properties
| Property | Value |
|---|---|
| applicant_name | ANI PHARMACEUTICALS INC |
| application_type | ANDA |
| approval_date | 2016-07-13 |
Products (6)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| TEMOZOLOMIDE | TEMOZOLOMIDE | 5MG | CAPSULE;ORAL |
| TEMOZOLOMIDE | TEMOZOLOMIDE | 250MG | CAPSULE;ORAL |
| TEMOZOLOMIDE | TEMOZOLOMIDE | 20MG | CAPSULE;ORAL |
| TEMOZOLOMIDE | TEMOZOLOMIDE | 100MG | CAPSULE;ORAL |
| TEMOZOLOMIDE | TEMOZOLOMIDE | 140MG | CAPSULE;ORAL |
| TEMOZOLOMIDE | TEMOZOLOMIDE | 180MG | CAPSULE;ORAL |
6 products