Prevents organ rejection. ANDA 214630, held by Biocon Pharma. Mycophenolate Sodium.
As of Nov 14, 2026, ANDA 214630 (Mycophenolate Sodium), held by Biocon Pharma, was first approved by FDA on Nov 29, 2021, with 3 approved supplements and 0 published complete response letters.
Mycophenolic acid delayed-release tablets are 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 |
|---|---|---|---|
| Nov 29, 2021 | Original application | Approved |
| Mycophenolate SodiumEQ 180MG BASE · tablet, delayed release;oral | Mycophenolate Sodium | Rx |
| Mycophenolate SodiumEQ 360MG BASE · tablet, delayed release;oral | Mycophenolate Sodium | Rx |
| Jul 29, 2026 | Supplement 14REMS | Approved | None posted |
| Aug 13, 2024 | Supplement 7REMS | Approved | None posted |
| Jan 10, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Nov 29, 2021 | 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
