APPLICATION
ANDA065491
TYPE
ANDA
ORIGINAL APPROVAL
2009-05-06
LATEST ACTION
2026-07-29
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
MYCOPHENOLATE MOFETILPrescription
MYCOPHENOLATE MOFETIL 250MG · CAPSULE · ORAL
Approval history
2026-07-29REMS · Supplement 34AP
2024-08-13REMS · Supplement 30AP
2021-08-11REMS · Supplement 23AP
2021-04-21REMS · Supplement 22AP
2021-01-15REMS · Supplement 21AP
2020-08-04Labeling · Supplement 19 · standardAP
2019-09-10Labeling · Supplement 18 · standardAP
2019-09-10Labeling · Supplement 17 · standardAP
2015-11-13REMS · Supplement 9AP
2015-10-30Labeling · Supplement 10 · standardAP
2013-09-27Labeling · Supplement 8 · standardAP
2012-09-25REMS · Supplement 6AP
2012-07-25Labeling · Supplement 7 · standardAP
2010-02-04Labeling · Supplement 5AP
2010-02-02Labeling · Supplement 4AP
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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