Prevents organ rejection in kidney, liver, and heart allogeneic transplants. NDA 50573, held by Novartis. Cyclosporine.
As of Nov 13, 2026, NDA 50573 (Sandimmune), held by Novartis, was first approved by FDA on Nov 14, 1983, with 35 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Sandimmune capsules and Sandimmune injection, in combination with adrenal corticosteroids, are indicated for the: Prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Treatment of chronic rejection in patients previously treated with other immunosuppressive agents. Because of the risk of anaphylaxis, Sandimmune injection should be reserved for patients who are unable to take the Sandimmune capsules.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 14, 1983 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sandimmune50MG/ML · injectable;injection | Cyclosporine | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 6, 2026 | Supplement 48Labeling · Standard review | Approved | |
| Sep 28, 2023 | Supplement 44Labeling · Standard review | Approved | |
| Nov 2, 2015 | Supplement 40Manufacturing · Priority review | Approved | None posted |
| Mar 31, 2015 | Supplement 41Labeling · Standard review | Approved | |
| May 3, 2013 | Supplement 39Labeling · Standard review | Approved | |
| Feb 7, 2013 | Supplement 38Manufacturing · Priority review | Approved | None posted |
| Aug 30, 2012 | Supplement 35Labeling · Standard review | Approved | |
| Apr 30, 2010 | Supplement 34Labeling | Approved | |
| Oct 8, 2009 | Supplement 33Labeling | Approved | |
| Mar 6, 2006 | Supplement 31Labeling · Standard review | Approved | |
| Jul 19, 2005 | Supplement 30Labeling · Standard review | Approved | |
| Feb 6, 2004 | Supplement 28Labeling · Standard review | Approved | |
| Feb 6, 2004 | Supplement 27Labeling · Standard review | Approved | |
| Feb 14, 2003 | Supplement 23Labeling · Standard review | Approved | |
| Feb 14, 2003 | Supplement 21Labeling · Standard review | Approved | |
| Apr 12, 2002 | Supplement 25Manufacturing · Priority review | Approved | None posted |
| Jan 16, 2002 | Supplement 24Manufacturing · Priority review | Approved | None posted |
| Apr 4, 2001 | Supplement 19Manufacturing · Priority review | Approved | None posted |
| Mar 9, 2001 | Supplement 20Manufacturing · Priority review | Approved | None posted |
| Oct 4, 2000 | Supplement 18Labeling · Standard review | Approved | None posted |
| Dec 21, 1999 | Supplement 17Labeling · Standard review | Approved | None posted |
| May 13, 1999 | Supplement 16Manufacturing · Priority review | Approved | None posted |
| Oct 20, 1998 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Mar 30, 1998 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Aug 9, 1996 | Supplement 12Labeling · Standard review | Approved | None posted |
| Aug 2, 1996 | Supplement 13Manufacturing · Priority review | Approved | None posted |
| Mar 7, 1995 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Nov 10, 1994 | Supplement 11Labeling · Standard review | Approved | None posted |
| May 9, 1994 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| May 9, 1994 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Mar 19, 1993 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Mar 19, 1993 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Mar 19, 1993 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Feb 21, 1992 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Jun 10, 1991 | Supplement 5Labeling | Approved | None posted |
| Nov 14, 1983 | Original applicationNew molecular entity · Priority 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
