Prevents organ rejection. NDA 50758, held by Roche Palo. Mycophenolate Mofetil Hydrochloride.
As of Nov 13, 2026, NDA 50758 (Cellcept), held by Roche Palo, was first approved by FDA on Aug 12, 1998, with 41 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 49Efficacy (new indication or use) · Standard review | Approved | |
| Jun 6, 2022 | Supplement 47Efficacy (new indication or use) · Standard review | Approved | |
| Jul 28, 2000 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Aug 12, 1998 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cellcept500MG/VIAL · injectable;injection | Mycophenolate Mofetil Hydrochloride | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 29, 2026 | Supplement 56Labeling · Standard review | Approved | |
| Jul 29, 2026 | Supplement 54REMS | Approved | |
| Jun 27, 2025 | Supplement 52Labeling · Standard review | Approved | |
| Aug 13, 2024 | Supplement 51REMS | Approved | |
| Aug 10, 2022 | Supplement 48Labeling · Standard review | Approved | |
| Jun 6, 2022 | Supplement 49Efficacy (new indication or use) · Standard review | Approved | |
| Jun 6, 2022 | Supplement 47Efficacy (new indication or use) · Standard review | Approved | |
| Oct 22, 2021 | Supplement 43Labeling · Standard review | Approved | |
| Oct 22, 2021 | Supplement 42Labeling · Standard review | Approved | |
| Aug 11, 2021 | Supplement 45REMS | Approved | |
| Apr 21, 2021 | Supplement 44REMS | Approved | |
| Jan 15, 2021 | Supplement 41REMS | Approved | |
| Dec 13, 2019 | Supplement 37Labeling · Standard review | Approved | |
| Feb 27, 2019 | Supplement 35Labeling · Standard review | Approved | |
| Aug 23, 2018 | Supplement 33Labeling · Standard review | Approved | |
| Dec 18, 2017 | Supplement 34Labeling · Standard review | Approved | |
| May 26, 2016 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Nov 13, 2015 | Supplement 31REMS | Approved | |
| Jul 9, 2015 | Supplement 30Labeling · Standard review | Approved | |
| Sep 27, 2013 | Supplement 29REMS | Approved | |
| Sep 27, 2013 | Supplement 28Labeling · Standard review | Approved | |
| Feb 14, 2013 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Sep 25, 2012 | Supplement 20REMS | Approved | |
| Jun 22, 2012 | Supplement 26Labeling · Standard review | Approved | |
| Jun 8, 2012 | Supplement 24Labeling · Standard review | Approved | |
| Oct 8, 2009 | Supplement 22Labeling | 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 16Labeling · Standard review | Approved | |
| Dec 20, 2007 | Supplement 13Labeling · Standard review | Approved | |
| Sep 21, 2007 | Supplement 14Labeling · Standard review | Approved | |
| Oct 17, 2005 | Supplement 12Labeling · Standard review | Approved | |
| Apr 12, 2005 | Supplement 10Labeling · Standard review | Approved | |
| Feb 28, 2003 | Supplement 5Labeling · Standard review | Approved | |
| Dec 17, 2002 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Feb 27, 2002 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Jul 28, 2000 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Jul 27, 2000 | Supplement 3Labeling · Standard review | Approved | |
| Jun 16, 2000 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Apr 20, 2000 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Aug 12, 1998 | Original applicationNew dosage form · Standard 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
