APPLICATION
ANDA204076
TYPE
ANDA
ORIGINAL APPROVAL
2017-11-16
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 8AP
2024-08-13REMS · Supplement 7AP
2024-06-06Labeling · Supplement 6 · standardAP
2024-06-06Manufacturing (CMC) · Supplement 5 · unknownAP
2021-08-11REMS · Supplement 4AP
2021-04-21REMS · Supplement 3AP
2021-01-15REMS · 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.