Prevents organ rejection. ANDA 217937, held by Aurobindo Pharma. Mycophenolate Mofetil.
As of Nov 14, 2026, ANDA 217937 (Mycophenolate Mofetil), held by Aurobindo Pharma, was first approved by FDA on Feb 20, 2024, with 3 approved supplements and 0 published complete response letters.
Mycophenolate mofetil tablets 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 |
|---|---|---|---|
| Feb 20, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mycophenolate Mofetil500MG · tablet;oral | Mycophenolate Mofetil | Rx |
| Jul 29, 2026 | Supplement 4REMS | Approved | None posted |
| Jan 14, 2026 | Supplement 2Labeling · Standard review | Approved | None posted |
| Aug 13, 2024 | Supplement 1REMS | Approved | None posted |
| Feb 20, 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
