Prevents organ rejection, in recipients of allogeneic kidney, heart or liver transplants. ANDA 214079, held by Wuxi. Mycophenolate Mofetil.
As of Nov 14, 2026, ANDA 214079 (Mycophenolate Mofetil), held by Wuxi, was first approved by FDA on Nov 7, 2024, with 1 approved supplement and 0 published complete response letters.
Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in recipients 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 |
|---|---|---|---|
| Nov 7, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mycophenolate Mofetil250MG · capsule;oral | Mycophenolate Mofetil | Rx |
| Jul 29, 2026 | Supplement 1REMS | Approved | None posted |
| Nov 7, 2024 | Original application | Approved | None posted |
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
