Prevents organ rejection. ANDA 211173, held by Concord Biotech Ltd. Mycophenolate Sodium.
As of Nov 14, 2026, ANDA 211173 (Mycophenolate Sodium), held by Concord Biotech Ltd, was first approved by FDA on Dec 13, 2019, with 5 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 |
|---|---|---|---|
| Dec 13, 2019 | 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 21REMS | Approved | None posted |
| Aug 13, 2024 | Supplement 16REMS | Approved | None posted |
| Aug 11, 2021 | Supplement 7REMS | Approved | None posted |
| Apr 21, 2021 | Supplement 6REMS | Approved | None posted |
| Jan 15, 2021 | Supplement 4REMS | Approved | None posted |
| Dec 13, 2019 | 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
