APPLICATION
ANDA065457
TYPE
ANDA
ORIGINAL APPROVAL
2009-05-04
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 18AP
2021-08-11REMS · Supplement 17AP
2021-04-21REMS · Supplement 16AP
2021-01-15REMS · Supplement 13AP
2015-11-13REMS · Supplement 9AP
2015-10-30Labeling · Supplement 10 · standardAP
2013-09-27Labeling · Supplement 6 · standardAP
2012-09-25REMS · Supplement 4AP
2012-07-25Labeling · Supplement 5 · standardAP
2010-02-04Labeling · Supplement 2AP
2010-02-02Labeling · 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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