APPLICATION
ANDA090456
TYPE
ANDA
ORIGINAL APPROVAL
2010-06-10
LATEST ACTION
2026-07-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MYCOPHENOLATE MOFETILPrescription
MYCOPHENOLATE MOFETIL 500MG · TABLET · ORAL
Approval history
2026-07-29REMS · Supplement 52AP
2025-02-12Labeling · Supplement 27 · standardAP
2025-02-12Labeling · Supplement 28 · standardAP
2025-02-12Labeling · Supplement 26 · standardAP
2025-02-12Labeling · Supplement 30 · standardAP
2024-08-13REMS · Supplement 37AP
2021-08-11REMS · Supplement 24AP
2021-04-21REMS · Supplement 23AP
2021-01-15REMS · Supplement 19AP
2020-08-04Labeling · Supplement 18 · standardAP
2019-11-22Labeling · Supplement 16 · standardAP
2016-08-01Labeling · Supplement 8 · standardAP
2015-11-13REMS · Supplement 7AP
2013-09-27Labeling · Supplement 6 · standardAP
2012-09-25Labeling · Supplement 4 · standardAP
2012-08-31Labeling · Supplement 5 · standardAP
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.