Application 065151
- Type
- ANDA
- Sponsor
- AM REGENT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CYCLOSPORINE | CYCLOSPORINE | INJECTABLE;INJECTION | 50MG/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0574-0866 | Cyclosporine | Cyclosporine | Perrigo Company | ANDA | Current |
| 0574-0866 | Cyclosporine | Cyclosporine | Padagis US LLC | ANDA | Current |
| 0574-0866 | Cyclosporine | Cyclosporine | Paddock Laboratories, LLC. | ANDA | Current |
| 0574-0866 | Cyclosporine | Cyclosporine | Perrigo Company | ANDA | Current |
| 63629-8640 | Cyclosporine | Cyclosporine | Bryant Ranch Prepack | ANDA | Current |
| 63629-8640 | Cyclosporine | Cyclosporine | Bryant Ranch Prepack | ANDA | Current |
| 63629-8640 | Cyclosporine | Cyclosporine | Bryant Ranch Prepack | ANDA | Current |