Prevents organ rejection. ANDA 212634, held by Strides Pharma Intl. Mycophenolate Mofetil.
As of Nov 14, 2026, ANDA 212634 (Mycophenolate Mofetil), held by Strides Pharma Intl, was first approved by FDA on Aug 29, 2023, with 4 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 |
|---|---|---|---|
| Aug 29, 2023 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mycophenolate Mofetil200MG/ML · for suspension;oral | Mycophenolate Mofetil | Rx |
| Jul 29, 2026 | Supplement 13REMS | Approved | None posted |
| Apr 10, 2026 | Supplement 10Labeling · Standard review | Approved | None posted |
| Aug 13, 2024 | Supplement 3REMS | Approved | None posted |
| May 1, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| Aug 29, 2023 | 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
