APPLICATION
ANDA200197
TYPE
ANDA
ORIGINAL APPROVAL
2013-06-13
LATEST ACTION
2026-07-29
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
MYCOPHENOLATE MOFETILPrescription
MYCOPHENOLATE MOFETIL 250MG · CAPSULE · ORAL
Approval history
2026-07-29REMS · Supplement 32AP
2024-08-13REMS · Supplement 27AP
2024-01-03Labeling · Supplement 25 · standardAP
2024-01-03Labeling · Supplement 23 · standardAP
2024-01-03Labeling · Supplement 24 · standardAP
2024-01-03Labeling · Supplement 22 · standardAP
2021-08-11REMS · Supplement 21AP
2021-04-21REMS · Supplement 20AP
2021-01-15REMS · Supplement 17AP
2020-08-12Labeling · Supplement 15 · standardAP
2019-09-10Labeling · Supplement 13 · standardAP
2019-09-10Labeling · Supplement 11 · standardAP
2015-11-13REMS · Supplement 3AP
2015-10-05Labeling · Supplement 2 · standardAP
2013-09-27Labeling · Supplement 1 · 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.