APPLICATION
ANDA065520
TYPE
ANDA
ORIGINAL APPROVAL
2009-05-04
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 40AP
2024-08-13REMS · Supplement 36AP
2023-01-11Labeling · Supplement 34 · standardAP
2022-03-08Labeling · Supplement 32 · standardAP
2021-08-11REMS · Supplement 30AP
2021-05-04Labeling · Supplement 25 · standardAP
2021-04-21REMS · Supplement 28AP
2021-01-15REMS · Supplement 26AP
2019-09-11Labeling · Supplement 22 · standardAP
2019-09-11Labeling · Supplement 20 · standardAP
2015-11-13REMS · Supplement 16AP
2015-10-30Labeling · Supplement 17 · standardAP
2013-09-27Labeling · Supplement 13 · standardAP
2012-09-25REMS · Supplement 9AP
2012-08-09Labeling · Supplement 10 · 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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