Prevents organ rejection. ANDA 91248, held by Rk Pharma. Mycophenolate Sodium.
As of Nov 15, 2026, ANDA 91248 (Mycophenolate Sodium), held by Rk Pharma, was first approved by FDA on Jan 8, 2014, with 6 approved supplements and 0 published complete response letters.
Mycophenolic acid delayed-release tablets are an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. Use in combination with cyclosporine and corticosteroids. Limitations of Use: Mycophenolic acid delayed-release tablets and mycophenolate mofetil tablets and capsules should not be used interchangeably. 1.1 Prophylaxis of Organ Rejection in Kidney Transplant Mycophenolic acid delayed-release tablets are indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 8, 2014 | Original application | Approved |
| Mycophenolate SodiumEQ 360MG BASE · tablet, delayed release;oral | Mycophenolate Sodium | Discontinued |
| Mycophenolate SodiumEQ 180MG BASE · tablet, delayed release;oral | Mycophenolate Sodium | Discontinued |
| Jul 29, 2026 | Supplement 22REMS | Approved | None posted |
| Aug 13, 2024 | Supplement 20REMS | Approved | None posted |
| Aug 11, 2021 | Supplement 17REMS | Approved | None posted |
| Apr 21, 2021 | Supplement 15REMS | Approved | None posted |
| Jan 15, 2021 | Supplement 14REMS | Approved | None posted |
| Nov 13, 2015 | Supplement 3REMS | Approved | None posted |
| Jan 8, 2014 | 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
