Prevents organ rejection. ANDA 217828, held by Aurobindo Pharma Ltd. Mycophenolate Mofetil.
As of Nov 14, 2026, ANDA 217828 (Mycophenolate Mofetil), held by Aurobindo Pharma Ltd, was first approved by FDA on Jan 5, 2024, with 3 approved supplements and 0 published complete response letters.
Mycophenolate mofetil capsules are 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 |
|---|---|---|---|
| Jan 5, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mycophenolate Mofetil250MG · capsule;oral | Mycophenolate Mofetil | Rx |
| Jul 29, 2026 | Supplement 5REMS | Approved | None posted |
| Jan 14, 2026 | Supplement 3Labeling · Standard review | Approved | None posted |
| Aug 13, 2024 | Supplement 1REMS | Approved | None posted |
| Jan 5, 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
