Prevents organ rejection. ANDA 208119, held by Hetero Labs Ltd V. Mycophenolate Mofetil.
As of Nov 14, 2026, ANDA 208119 (Mycophenolate Mofetil), held by Hetero Labs Ltd V, was first approved by FDA on Oct 22, 2024, with 2 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 tablets are 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 |
|---|---|---|---|
| Oct 22, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mycophenolate Mofetil500MG · tablet;oral | Mycophenolate Mofetil | Rx |
| Aug 7, 2026 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jul 29, 2026 | Supplement 6REMS | Approved | None posted |
| Oct 22, 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
