APPLICATION
ANDA065451
TYPE
ANDA
ORIGINAL APPROVAL
2008-10-15
LATEST ACTION
2026-07-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MYCOPHENOLATE MOFETILPrescription
MYCOPHENOLATE MOFETIL 500MG · TABLET · ORAL
Approval history
2026-07-29REMS · Supplement 43AP
2024-08-13REMS · Supplement 38AP
2023-01-30Labeling · Supplement 33 · standardAP
2023-01-30Labeling · Supplement 34 · standardAP
2022-03-08Labeling · Supplement 32 · standardAP
2021-08-11REMS · Supplement 30AP
2021-05-17Labeling · Supplement 26 · standardAP
2021-04-21REMS · Supplement 28AP
2021-01-15REMS · Supplement 27AP
2019-09-11Labeling · Supplement 25 · standardAP
2019-09-11Labeling · Supplement 22 · standardAP
2015-11-13REMS · Supplement 18AP
2015-11-09Labeling · Supplement 19 · standardAP
2013-09-27Labeling · Supplement 16 · standardAP
2012-10-12Labeling · Supplement 10 · standardAP
2012-09-25REMS · Supplement 9AP
2010-02-02Labeling · Supplement 3AP
2009-03-24Labeling · 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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