Prevents organ rejection. ANDA 214871, held by Amneal. Mycophenolate Mofetil.
As of Nov 14, 2026, ANDA 214871 (Mycophenolate Mofetil), held by Amneal, was first approved by FDA on Nov 2, 2021, with 5 approved supplements and 0 published complete response letters.
Mycophenolate mofetil for oral suspension 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 for oral suspension 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 2, 2021 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mycophenolate Mofetil200MG/ML · for suspension;oral | Mycophenolate Mofetil | Rx |
| Jul 29, 2026 | Supplement 13REMS | Approved | None posted |
| Feb 23, 2026 | Supplement 11Labeling · Standard review | Approved | None posted |
| Aug 13, 2024 | Supplement 8REMS | Approved | None posted |
| Dec 21, 2022 | Supplement 4Labeling · Standard review | Approved | None posted |
| Dec 21, 2022 | Supplement 1Labeling · Standard review | Approved | None posted |
| Nov 2, 2021 | 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
