Prevents organ rejection in kidney, liver, and heart allogeneic transplants. ANDA 219652, held by Aurobindo Pharma Ltd. Cyclosporine.
As of Nov 15, 2026, ANDA 219652 (Cyclosporine), held by Aurobindo Pharma Ltd, was first approved by FDA on Sep 17, 2026, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Kidney, Liver, and Heart Transplantation Cyclosporine capsules (modified) are indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine capsules (modified) has been used in combination with azathioprine and corticosteroids. Rheumatoid Arthritis Cyclosporine capsules (modified) are indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Cyclosporine capsules (modified) can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 17, 2026 | Original application | Approved | None posted |
| Cyclosporine25MG · capsule;oral | Cyclosporine | Rx |
| Cyclosporine50MG · capsule;oral | Cyclosporine | Rx |
| Cyclosporine100MG · capsule;oral | Cyclosporine | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
