APPLICATION
ANDA090111
TYPE
ANDA
ORIGINAL APPROVAL
2009-12-22
LATEST ACTION
2026-07-29
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
MYCOPHENOLATE MOFETILDiscontinued
MYCOPHENOLATE MOFETIL 250MG · CAPSULE · ORAL
Approval history
2026-07-29REMS · Supplement 17AP
2024-08-13REMS · Supplement 15AP
2023-06-06Labeling · Supplement 13 · standardAP
2023-06-06Labeling · Supplement 14 · standardAP
2021-08-11REMS · Supplement 12AP
2021-04-21REMS · Supplement 11AP
2021-01-15REMS · Supplement 10AP
2016-07-27Labeling · Supplement 9 · standardAP
2015-11-13REMS · Supplement 8AP
2013-09-27REMS · Supplement 7AP
2012-09-25REMS · Supplement 4AP
2012-08-01Labeling · Supplement 5 · 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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