ANDA 65520, held by Mylan. Mycophenolate Mofetil.
As of Nov 14, 2026, ANDA 65520 (Mycophenolate Mofetil), held by Mylan, was first approved by FDA on May 4, 2009, with 17 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 4, 2009 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mycophenolate Mofetil250MG · capsule;oral | Mycophenolate Mofetil | Discontinued |
| Jul 29, 2026 | Supplement 40REMS | Approved | None posted |
| Aug 13, 2024 | Supplement 36REMS | Approved | None posted |
| Jan 11, 2023 | Supplement 34Labeling · Standard review | Approved | None posted |
| Mar 8, 2022 | Supplement 32Labeling · Standard review | Approved | None posted |
| Aug 11, 2021 | Supplement 30REMS | Approved | None posted |
| May 4, 2021 | Supplement 25Labeling · Standard review | Approved | None posted |
| Apr 21, 2021 | Supplement 28REMS | Approved | None posted |
| Jan 15, 2021 | Supplement 26REMS | Approved | None posted |
| Sep 11, 2019 | Supplement 22Labeling · Standard review | Approved | None posted |
| Sep 11, 2019 | Supplement 20Labeling · Standard review | Approved | None posted |
| Nov 13, 2015 | Supplement 16REMS | Approved | None posted |
| Oct 30, 2015 | Supplement 17Labeling · Standard review | Approved | None posted |
| Sep 27, 2013 | Supplement 13Labeling · Standard review | Approved | None posted |
| Sep 25, 2012 | Supplement 9REMS | Approved | None posted |
| Aug 9, 2012 | Supplement 10Labeling · Standard review | Approved | None posted |
| Feb 4, 2010 | Supplement 4Labeling | Approved | None posted |
| Jan 29, 2010 | Supplement 3Labeling | Approved | None posted |
| May 4, 2009 | 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
