Prevents organ rejection. ANDA 212087, held by Concord Biotech Ltd. Mycophenolate Mofetil.
As of Nov 14, 2026, ANDA 212087 (Mycophenolate Mofetil), held by Concord Biotech Ltd, was first approved by FDA on Jul 31, 2020, with 7 approved supplements and 0 published complete response letters.
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. 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 31, 2020 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mycophenolate Mofetil500MG · tablet;oral | Mycophenolate Mofetil | Rx |
| Jul 29, 2026 | Supplement 17REMS | Approved | None posted |
| Aug 13, 2024 | Supplement 14REMS | Approved | None posted |
| Jul 8, 2024 | Supplement 11Labeling · Standard review | Approved | None posted |
| Nov 16, 2022 | Supplement 9Labeling · Standard review | Approved | None posted |
| Aug 11, 2021 | Supplement 4REMS | Approved | None posted |
| Apr 21, 2021 | Supplement 3REMS | Approved | None posted |
| Jan 15, 2021 | Supplement 2REMS | Approved | None posted |
| Jul 31, 2020 | 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
