APPLICATION
ANDA091558
TYPE
ANDA
ORIGINAL APPROVAL
2012-08-21
LATEST ACTION
2026-07-29
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
MYCOPHENOLATE SODIUMPrescription
MYCOPHENOLATE SODIUM EQ 180MG BASE · TABLET, DELAYED RELEASE · ORAL
MYCOPHENOLATE SODIUMPrescription
MYCOPHENOLATE SODIUM EQ 360MG BASE · TABLET, DELAYED RELEASE · ORAL
Approval history
2026-07-29REMS · Supplement 29AP
2024-08-13REMS · Supplement 22AP
2023-11-28Labeling · Supplement 19 · standardAP
2023-11-28Labeling · Supplement 17 · standardAP
2023-11-28Labeling · Supplement 14 · standardAP
2021-08-11REMS · Supplement 18AP
2021-04-21REMS · Supplement 16AP
2021-01-15REMS · Supplement 12AP
2019-12-31Labeling · Supplement 8 · standardAP
2015-11-13REMS · Supplement 6AP
2014-08-19OriginalAP
2014-06-26Labeling · Supplement 3 · standardAP
2013-09-30REMS · Supplement 2AP
2012-09-25REMS · 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.
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