APPLICATION
ANDA065521
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 38AP
2024-08-13REMS · Supplement 34AP
2023-01-11Labeling · Supplement 32 · standardAP
2022-03-08Labeling · Supplement 30 · standardAP
2021-08-11REMS · Supplement 28AP
2021-05-04Labeling · Supplement 23 · standardAP
2021-04-21REMS · Supplement 26AP
2021-01-15REMS · Supplement 24AP
2019-09-11Labeling · Supplement 18 · standardAP
2019-09-11Labeling · Supplement 20 · standardAP
2015-11-13REMS · Supplement 13AP
2015-10-30Labeling · Supplement 14 · standardAP
2013-09-27Labeling · Supplement 10AP
2012-09-25REMS · Supplement 8AP
2012-08-09Labeling · Supplement 9 · standardAP
2010-02-04Labeling · Supplement 4AP
2010-01-29Labeling · Supplement 3AP
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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