Prevents organ rejection. NDA 50723, held by Roche Palo. Mycophenolate Mofetil.
As of Nov 13, 2026, NDA 50723 (Cellcept), held by Roche Palo, was first approved by FDA on Jun 19, 1997, with 42 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.
| 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 4Efficacy (new indication or use) · Standard review | Approved | |
| Jul 28, 2000 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Jun 19, 1997 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cellcept500MG · tablet;oral | Mycophenolate Mofetil | RxReference drug |
| 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 41Labeling · 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 | |
| Oct 27, 2016 | Supplement 34Manufacturing | Approved | None posted |
| Nov 13, 2015 | Supplement 33REMS | Approved | |
| Jul 9, 2015 | Supplement 32Labeling · Standard review | Approved | |
| Jan 23, 2014 | Supplement 31Manufacturing · Priority review | Approved | None posted |
| Sep 27, 2013 | Supplement 30REMS | Approved | |
| Sep 27, 2013 | Supplement 29Labeling · Standard review | Approved | |
| Feb 14, 2013 | Supplement 26Manufacturing · Priority review | Approved | None posted |
| Sep 25, 2012 | Supplement 20REMS | Approved | |
| Jun 22, 2012 | Supplement 27Labeling · Standard review | Approved | |
| Jun 8, 2012 | Supplement 25Labeling · Standard review | Approved | |
| Oct 8, 2009 | Supplement 23Labeling | Approved | |
| Jul 22, 2009 | Supplement 21Manufacturing | Approved | |
| Jun 18, 2009 | Supplement 19Labeling · Standard review | Approved | |
| Feb 27, 2009 | Supplement 18Labeling · Standard review | Approved | |
| Dec 15, 2008 | Supplement 17Labeling · Standard review | Approved | |
| May 9, 2008 | Supplement 15Labeling · Standard review | Approved | |
| Dec 20, 2007 | Supplement 12Labeling · Standard review | Approved | |
| Sep 21, 2007 | Supplement 13Labeling · Standard review | Approved | |
| Oct 17, 2005 | Supplement 10Labeling · Standard review | Approved | |
| Feb 28, 2003 | Supplement 6Labeling · Standard review | Approved | |
| Dec 17, 2002 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Dec 20, 2000 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Jul 28, 2000 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Jul 27, 2000 | Supplement 3Labeling · Standard review | Approved | |
| Jun 16, 2000 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Feb 11, 1998 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jun 19, 1997 | Original applicationNew dosage form · 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
