Prevents organ rejection. ANDA 210370, held by Vistapharm LLC. Mycophenolate Mofetil.
As of Nov 14, 2026, ANDA 210370 (Mycophenolate Mofetil), held by Vistapharm LLC, was first approved by FDA on Feb 12, 2019, with 9 approved supplements and 0 published complete response letters.
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. Mycophenolate mofetil 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 |
|---|---|---|---|
| Feb 12, 2019 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mycophenolate Mofetil200MG/ML · for suspension;oral | Mycophenolate Mofetil | Rx |
| Jul 29, 2026 | Supplement 23REMS | Approved | None posted |
| Aug 13, 2024 | Supplement 15REMS | Approved | None posted |
| Nov 10, 2022 | Supplement 4Labeling · Standard review | Approved | None posted |
| Nov 10, 2022 | Supplement 11Labeling · Standard review | Approved | None posted |
| Nov 10, 2022 | Supplement 12Labeling · Standard review | Approved | None posted |
| Aug 11, 2021 | Supplement 9REMS | Approved | None posted |
| Apr 21, 2021 | Supplement 8REMS | Approved | None posted |
| Jan 15, 2021 | Supplement 5REMS | Approved | None posted |
| Nov 25, 2019 | Supplement 2Labeling · Standard review | Approved | None posted |
| Feb 12, 2019 | Original application | 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
