Prevents organ rejection. ANDA 218227, held by Aurobindo Pharma Ltd. Mycophenolate Mofetil.
As of Nov 14, 2026, ANDA 218227 (Mycophenolate Mofetil), held by Aurobindo Pharma Ltd, was first approved by FDA on Sep 26, 2024, with 2 approved supplements and 0 published complete response letters.
Mycophenolate mofetil for oral suspension (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 |
|---|---|---|---|
| Sep 26, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mycophenolate Mofetil200MG/ML · for suspension;oral | Mycophenolate Mofetil | Rx |
| Jul 29, 2026 | Supplement 4REMS | Approved | None posted |
| Mar 18, 2026 | Supplement 1Labeling · Standard review | Approved | None posted |
| Sep 26, 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
