Prevents organ rejection in kidney, liver, and heart allogeneic transplants. NDA 50716, held by Novartis. Cyclosporine.
As of Nov 13, 2026, NDA 50716 (Neoral), held by Novartis, was first approved by FDA on Jul 14, 1995, with 27 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Kidney, Liver, and Heart Transplantation Neoral is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Neoral has been used in combination with azathioprine and corticosteroids. Rheumatoid Arthritis Neoral is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Neoral can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone. Psoriasis Neoral is indicated for the treatment of adult, nonimmunocompromised patients with severe (i.e.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 14, 1995 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Neoral100MG/ML · solution;oral | Cyclosporine | RxReference drug |
| Sep 26, 2023 | Supplement 41Labeling · Standard review | Approved | |
| Mar 31, 2015 | Supplement 38Labeling · Standard review | Approved | |
| Aug 29, 2013 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| May 2, 2013 | Supplement 34Labeling · Standard review | Approved | |
| Aug 30, 2012 | Supplement 30Labeling · Standard review | Approved | |
| Oct 8, 2009 | Supplement 29Labeling | Approved | |
| Sep 24, 2009 | Supplement 28Labeling · Standard review | Approved | |
| Aug 1, 2007 | Supplement 26Labeling · Standard review | Approved | |
| Mar 6, 2006 | Supplement 25Labeling · Standard review | Approved | |
| Jul 19, 2005 | Supplement 24Labeling · Standard review | Approved | |
| Feb 6, 2004 | Supplement 21Labeling · Standard review | Approved | |
| Feb 6, 2004 | Supplement 20Labeling · Standard review | Approved | |
| Jun 12, 2002 | Supplement 18Labeling · Standard review | Approved | |
| Jun 12, 2002 | Supplement 14Labeling · Standard review | Approved | |
| Apr 12, 2002 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Feb 22, 2002 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| May 3, 2001 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Nov 29, 2000 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Oct 4, 2000 | Supplement 11Labeling · Standard review | Approved | None posted |
| Dec 21, 1999 | Supplement 12Labeling · Standard review | Approved | None posted |
| May 13, 1999 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Jul 27, 1998 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Jul 24, 1998 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Mar 30, 1998 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Jan 30, 1998 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Jun 19, 1997 | Supplement 4Labeling · Standard review | Approved | None posted |
| Mar 5, 1997 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jul 14, 1995 | Original applicationNew dosage form · Standard review | 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
