APPLICATION
ANDA202720
TYPE
ANDA
ORIGINAL APPROVAL
2014-10-30
LATEST ACTION
2026-07-29
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued
Products
MYCOPHENOLATE SODIUMDiscontinued
MYCOPHENOLATE SODIUM EQ 360MG BASE · TABLET, DELAYED RELEASE · ORAL
MYCOPHENOLATE SODIUMDiscontinued
MYCOPHENOLATE SODIUM EQ 180MG BASE · TABLET, DELAYED RELEASE · ORAL
Approval history
2026-07-29REMS · Supplement 12AP
2024-08-13REMS · Supplement 11AP
2021-08-11REMS · Supplement 9AP
2021-04-21REMS · Supplement 8AP
2021-01-15REMS · Supplement 7AP
2019-11-21Labeling · Supplement 2 · standardAP
2015-11-13REMS · 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.