ANDA 65521, held by Mylan. Mycophenolate Mofetil.
As of Nov 14, 2026, ANDA 65521 (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 Mofetil500MG · tablet;oral | Mycophenolate Mofetil | Discontinued |
| Jul 29, 2026 | Supplement 38REMS | Approved | None posted |
| Aug 13, 2024 | Supplement 34REMS | Approved | None posted |
| Jan 11, 2023 | Supplement 32Labeling · Standard review | Approved | None posted |
| Mar 8, 2022 | Supplement 30Labeling · Standard review | Approved | None posted |
| Aug 11, 2021 | Supplement 28REMS | Approved | None posted |
| May 4, 2021 | Supplement 23Labeling · Standard review | Approved | None posted |
| Apr 21, 2021 | Supplement 26REMS | Approved | None posted |
| Jan 15, 2021 | Supplement 24REMS | Approved | None posted |
| Sep 11, 2019 | Supplement 18Labeling · Standard review | Approved | None posted |
| Sep 11, 2019 | Supplement 20Labeling · Standard review | Approved | None posted |
| Nov 13, 2015 | Supplement 13REMS | Approved | None posted |
| Oct 30, 2015 | Supplement 14Labeling · Standard review | Approved | None posted |
| Sep 27, 2013 | Supplement 10Labeling | Approved | None posted |
| Sep 25, 2012 | Supplement 8REMS | Approved | None posted |
| Aug 9, 2012 | Supplement 9Labeling · 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
