Prevents organ rejection in kidney, liver, and heart allogeneic transplants. ANDA 65110, held by Ivax Sub Teva Pharms. Cyclosporine.
As of Nov 15, 2026, ANDA 65110 (Cyclosporine), held by Ivax Sub Teva Pharms, was first approved by FDA on Mar 29, 2005, with 5 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Kidney, Liver, and Heart Transplantation Cyclosporine capsules, USP MODIFIED are indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine capsules, USP MODIFIED have been used in combination with azathioprine and corticosteroids. Rheumatoid Arthritis Cyclosporine capsules, USP MODIFIED are indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Cyclosporine capsules, USP MODIFIED can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 29, 2005 | Original application | Approved | None posted |
| Cyclosporine50MG · capsule;oral | Cyclosporine | Rx |
| Cyclosporine100MG · capsule;oral | Cyclosporine | Rx |
| Cyclosporine25MG · capsule;oral | Cyclosporine | Rx |
| Sep 24, 2015 | Supplement 9Labeling · Standard review | Approved | None posted |
| Sep 24, 2015 | Supplement 10Labeling · Standard review | Approved | None posted |
| Mar 26, 2013 | Supplement 7Labeling · Standard review | Approved | None posted |
| Sep 23, 2010 | Supplement 4Labeling | Approved | None posted |
| Nov 6, 2007 | Supplement 1Labeling | Approved | None posted |
| Mar 29, 2005 | Original application | Approved | None posted |
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
