APPLICATION
ANDA214525
TYPE
ANDA
ORIGINAL APPROVAL
2021-07-29
LATEST ACTION
2026-07-29
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription
Products
MYCOPHENOLATE MOFETILPrescription
MYCOPHENOLATE MOFETIL 200MG/ML · FOR SUSPENSION · ORAL
Approval history
2026-07-29REMS · Supplement 12AP
2024-08-13REMS · Supplement 7AP
2022-12-21Labeling · Supplement 4 · standardAP
2022-12-21Labeling · Supplement 2 · standardAP
2022-12-21Labeling · Supplement 3 · standardAP
2021-08-11REMS · 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.