APPLICATION
ANDA090606
TYPE
ANDA
ORIGINAL APPROVAL
2010-07-16
LATEST ACTION
2026-07-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
MYCOPHENOLATE MOFETILDiscontinued
MYCOPHENOLATE MOFETIL 500MG · TABLET · ORAL
Approval history
2026-07-29REMS · Supplement 19AP
2024-08-13REMS · Supplement 15AP
2021-08-11REMS · Supplement 11AP
2021-04-21REMS · Supplement 10AP
2021-01-15REMS · Supplement 9AP
2016-07-27Labeling · Supplement 8 · standardAP
2015-11-13REMS · Supplement 7AP
2013-09-27REMS · Supplement 6AP
2012-09-25REMS · Supplement 3AP
2012-08-01Labeling · Supplement 4 · 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.
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