Application 216046
- Type
- ANDA
- Sponsor
- STRIDES PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CYCLOSPORINE | CYCLOSPORINE | CAPSULE;ORAL | 25MG | No | No |
| 002 | CYCLOSPORINE | CYCLOSPORINE | CAPSULE;ORAL | 50MG | No | No |
| 003 | CYCLOSPORINE | CYCLOSPORINE | CAPSULE;ORAL | 100MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 23155-837 | CYCLOSPORINE | CYCLOSPORINE | Avet Pharmaceuticals Inc | ANDA | Current |
| 23155-838 | CYCLOSPORINE | CYCLOSPORINE | Avet Pharmaceuticals Inc | ANDA | Current |
| 23155-839 | CYCLOSPORINE | CYCLOSPORINE | Avet Pharmaceuticals Inc | ANDA | Current |
| 64380-127 | Cyclosporine | Cyclosporine | Strides Pharma Science Limited | ANDA | Current |
| 64380-128 | Cyclosporine | Cyclosporine | Strides Pharma Science Limited | ANDA | Current |
| 64380-129 | Cyclosporine | Cyclosporine | Strides Pharma Science Limited | ANDA | Current |