APPLICATION
ANDA091249
TYPE
ANDA
ORIGINAL APPROVAL
2011-11-04
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 34AP
2024-08-13REMS · Supplement 30AP
2024-01-03Labeling · Supplement 28 · standardAP
2024-01-03Labeling · Supplement 26 · standardAP
2024-01-03Labeling · Supplement 27 · standardAP
2024-01-03Labeling · Supplement 25 · standardAP
2021-08-11REMS · Supplement 24AP
2021-04-21REMS · Supplement 23AP
2021-01-15REMS · Supplement 20AP
2020-08-12Labeling · Supplement 18 · standardAP
2019-09-10Labeling · Supplement 16 · standardAP
2019-09-10Labeling · Supplement 14 · standardAP
2015-11-13REMS · Supplement 6AP
2015-10-06Labeling · Supplement 5 · standardAP
2013-09-27Labeling · Supplement 3 · standardAP
2012-09-25Labeling · Supplement 2 · standardAP
2012-08-09Labeling · Supplement 1 · 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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