APPLICATION
ANDA065413
TYPE
ANDA
ORIGINAL APPROVAL
2008-07-29
LATEST ACTION
2026-07-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
MYCOPHENOLATE MOFETILDiscontinued
MYCOPHENOLATE MOFETIL 500MG · TABLET · ORAL
Approval history
2026-07-29REMS · Supplement 26AP
2024-08-13REMS · Supplement 24AP
2024-02-07Labeling · Supplement 23 · standardAP
2024-02-07Labeling · Supplement 21 · standardAP
2024-02-07Labeling · Supplement 22 · standardAP
2021-08-11REMS · Supplement 20AP
2021-05-17Labeling · Supplement 17 · standardAP
2021-04-21REMS · Supplement 18AP
2021-01-15REMS · Supplement 15AP
2020-06-16Labeling · Supplement 14 · standardAP
2019-11-27Labeling · Supplement 13 · standardAP
2015-11-13REMS · Supplement 10AP
2015-10-30Labeling · Supplement 11 · standardAP
2014-09-12Manufacturing (CMC) · Supplement 6AP
2013-09-27Labeling · Supplement 9 · standardAP
2012-09-25REMS · Supplement 8AP
2012-07-25Labeling · Supplement 7 · standardAP
2010-02-02Labeling · Supplement 4AP
2009-09-09Labeling · Supplement 3AP
2009-02-20Labeling · Supplement 2AP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.