Prevents organ rejection in kidney, liver, and heart allogeneic transplants. ANDA 65044, held by Dr Reddys Labs SA. Cyclosporine.
As of Nov 15, 2026, ANDA 65044 (Cyclosporine), held by Dr Reddys Labs SA, was first approved by FDA on Dec 20, 2000, with 7 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Kidney, Liver, and Heart Transplantation Cyclosporine capsules, USP [MODIFIED] and cyclosporine oral solution, USP [MODIFIED] are indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine capsules, USP [MODIFIED] and cyclosporine oral solution, USP [MODIFIED] have been used in combination with azathioprine and corticosteroids. Rheumatoid Arthritis Cyclosporine capsules, USP [MODIFIED] and cyclosporine oral solution, USP [MODIFIED] are indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 20, 2000 | Original application | Approved |
| Cyclosporine100MG · capsule;oral | Cyclosporine | Rx |
| Cyclosporine25MG · capsule;oral | Cyclosporine | Rx |
| Jan 20, 2015 | Supplement 17Labeling · Standard review | Approved | None posted |
| Nov 16, 2007 | Supplement 10Labeling | Approved | None posted |
| Feb 5, 2007 | Supplement 8Labeling | Approved | None posted |
| Dec 2, 2004 | Supplement 4Labeling | Approved | None posted |
| May 14, 2004 | Supplement 3Labeling | Approved | None posted |
| May 3, 2002 | Supplement 2Labeling | Approved | None posted |
| May 3, 2002 | Supplement 1Labeling | Approved | None posted |
| Dec 20, 2000 | Original application | Approved |
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
