Prevents organ rejection. ANDA 210181, held by Concord Biotech Ltd. Mycophenolate Mofetil.
As of Nov 14, 2026, ANDA 210181 (Mycophenolate Mofetil), held by Concord Biotech Ltd, was first approved by FDA on Jan 8, 2019, with 8 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 |
|---|---|---|---|
| Jan 8, 2019 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mycophenolate Mofetil250MG · capsule;oral | Mycophenolate Mofetil | Rx |
| Jul 29, 2026 | Supplement 25REMS | Approved | None posted |
| Aug 13, 2024 | Supplement 20REMS | Approved | None posted |
| Jul 8, 2024 | Supplement 18Labeling · Standard review | Approved | None posted |
| Nov 16, 2022 | Supplement 15Labeling · 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 6REMS | Approved | None posted |
| Nov 25, 2019 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jan 8, 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
