Prevents organ rejection in kidney, liver, and heart allogeneic transplants. ANDA 65078, held by Ivax Sub Teva Pharms. Cyclosporine.
As of Nov 15, 2026, ANDA 65078 (Cyclosporine), held by Ivax Sub Teva Pharms, was first approved by FDA on Mar 25, 2005, with 5 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Kidney, Liver, and Heart Transplantation Cyclosporine oral solution, USP MODIFIED is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine oral solution, USP MODIFIED has been used in combination with azathioprine and corticosteroids. Rheumatoid Arthritis Cyclosporine oral solution, USP MODIFIED is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Cyclosporine oral solution, 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 25, 2005 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cyclosporine100MG/ML · solution;oral | Cyclosporine | Rx |
| Sep 24, 2015 | Supplement 9Labeling · Standard review | Approved | None posted |
| Sep 24, 2015 | Supplement 8Labeling · Standard review | Approved | None posted |
| Dec 11, 2012 | Supplement 7Labeling · Standard review | Approved | None posted |
| Aug 26, 2010 | Supplement 4Labeling | Approved | None posted |
| Oct 12, 2007 | Supplement 1Labeling | Approved | None posted |
| Mar 25, 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
