Prevents organ rejection. NDA 50722, held by Roche Palo. Mycophenolate Mofetil.
As of Nov 13, 2026, NDA 50722 (Cellcept), held by Roche Palo, was first approved by FDA on May 3, 1995, with 43 approved supplements and 0 published complete response letters.
CELLCEPT [mycophenolate mofetil (MMF)] is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants. CELLCEPT is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 6, 2022 | Supplement 51Efficacy (new indication or use) · Standard review | Approved | |
| Jun 6, 2022 | Supplement 49Efficacy (new indication or use) · Standard review | Approved | |
| Dec 20, 2000 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Jul 28, 2000 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Feb 11, 1998 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | None posted |
| May 3, 1995 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cellcept250MG · capsule;oral | Mycophenolate Mofetil | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 29, 2026 | Supplement 58Labeling · Standard review | Approved | |
| Jul 29, 2026 | Supplement 56REMS | Approved | |
| Jun 27, 2025 | Supplement 54Labeling · Standard review | Approved | |
| Aug 13, 2024 | Supplement 53REMS | Approved | |
| Aug 10, 2022 | Supplement 50Labeling · Standard review | Approved | |
| Jun 6, 2022 | Supplement 51Efficacy (new indication or use) · Standard review | Approved | |
| Jun 6, 2022 | Supplement 49Efficacy (new indication or use) · Standard review | Approved | |
| Oct 22, 2021 | Supplement 46Labeling · Standard review | Approved | |
| Oct 22, 2021 | Supplement 45Labeling · Standard review | Approved | |
| Aug 11, 2021 | Supplement 48REMS | Approved | |
| Apr 21, 2021 | Supplement 47REMS | Approved | |
| Jan 15, 2021 | Supplement 44REMS | Approved | |
| Dec 13, 2019 | Supplement 40Labeling · Standard review | Approved | |
| Feb 27, 2019 | Supplement 38Labeling · Standard review | Approved | |
| Aug 23, 2018 | Supplement 35Labeling · Standard review | Approved | |
| Dec 18, 2017 | Supplement 37Labeling · Standard review | Approved | |
| Nov 13, 2015 | Supplement 34REMS | Approved | |
| Jul 9, 2015 | Supplement 33Labeling · Standard review | Approved | |
| Jan 23, 2014 | Supplement 32Manufacturing · Priority review | Approved | None posted |
| Sep 27, 2013 | Supplement 31REMS | Approved | |
| Sep 27, 2013 | Supplement 30Labeling · Standard review | Approved | |
| Feb 14, 2013 | Supplement 27Manufacturing · Priority review | Approved | None posted |
| Sep 25, 2012 | Supplement 22REMS | Approved | |
| Jun 22, 2012 | Supplement 28Labeling · Standard review | Approved | |
| Jun 8, 2012 | Supplement 26Labeling · Standard review | Approved | |
| Oct 8, 2009 | Supplement 24Labeling | Approved | |
| Jun 18, 2009 | Supplement 21Labeling · Standard review | Approved | |
| Feb 27, 2009 | Supplement 20Labeling · Standard review | Approved | |
| Dec 15, 2008 | Supplement 19Labeling · Standard review | Approved | |
| May 9, 2008 | Supplement 18Labeling · Standard review | Approved | |
| Dec 20, 2007 | Supplement 15Labeling · Standard review | Approved | |
| Sep 21, 2007 | Supplement 16Labeling · Standard review | Approved | |
| Oct 17, 2005 | Supplement 13Labeling · Standard review | Approved | |
| Feb 28, 2003 | Supplement 8Labeling · Standard review | Approved | |
| May 31, 2002 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Nov 14, 2001 | Supplement 9Manufacturing · Priority review | Approved | |
| Dec 20, 2000 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Jul 28, 2000 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Jul 27, 2000 | Supplement 4Labeling · Standard review | Approved | |
| May 15, 2000 | Supplement 6Manufacturing · Priority review | Approved | |
| Apr 13, 1998 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Feb 11, 1998 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | None posted |
| Jun 12, 1997 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| May 3, 1995 | Original applicationNew molecular entity · Priority review | 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
