APPLICATION
ANDA090253
TYPE
ANDA
ORIGINAL APPROVAL
2009-05-04
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 27AP
2024-08-13REMS · Supplement 25AP
2024-08-09Labeling · Supplement 23 · standardAP
2023-09-18Labeling · Supplement 22 · standardAP
2021-08-11REMS · Supplement 21AP
2021-05-17Labeling · Supplement 19 · standardAP
2021-04-21REMS · Supplement 20AP
2021-01-15REMS · Supplement 18AP
2019-09-11Labeling · Supplement 16 · standardAP
2015-11-13REMS · Supplement 11AP
2015-11-06Labeling · Supplement 12 · standardAP
2015-06-01Labeling · Supplement 10 · standardAP
2013-09-27REMS · Supplement 9AP
2012-09-25REMS · Supplement 6AP
2012-08-24Labeling · Supplement 7 · standardAP
2009-11-30Labeling · Supplement 3AP
2009-09-08Labeling · Supplement 1AP
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.