Prevents organ rejection. ANDA 214525, held by Quagen. Mycophenolate Mofetil.
As of Nov 14, 2026, ANDA 214525 (Mycophenolate Mofetil), held by Quagen, was first approved by FDA on Jul 29, 2021, with 6 approved supplements and 0 published complete response letters.
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. 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 |
|---|---|---|---|
| Jul 29, 2021 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mycophenolate Mofetil200MG/ML · for suspension;oral | Mycophenolate Mofetil | Rx |
| Jul 29, 2026 | Supplement 12REMS | Approved | None posted |
| Aug 13, 2024 | Supplement 7REMS | Approved | None posted |
| Dec 21, 2022 | Supplement 2Labeling · Standard review | Approved | None posted |
| Dec 21, 2022 | Supplement 3Labeling · Standard review | Approved | None posted |
| Dec 21, 2022 | Supplement 4Labeling · Standard review | Approved | None posted |
| Aug 11, 2021 | Supplement 1REMS | Approved | None posted |
| Jul 29, 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
