APPLICATION
ANDA090055
TYPE
ANDA
ORIGINAL APPROVAL
2010-06-10
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 46AP
2025-02-12Labeling · Supplement 27 · standardAP
2025-02-12Labeling · Supplement 23 · standardAP
2025-02-12Labeling · Supplement 26 · standardAP
2025-02-12Labeling · Supplement 24 · standardAP
2024-08-13REMS · Supplement 33AP
2021-08-11REMS · Supplement 21AP
2021-04-21REMS · Supplement 20AP
2021-01-15REMS · Supplement 17AP
2020-08-04Labeling · Supplement 16 · standardAP
2019-11-22Labeling · Supplement 14 · standardAP
2016-08-01Labeling · Supplement 6 · standardAP
2015-11-13REMS · Supplement 5AP
2013-09-27Labeling · Supplement 4 · standardAP
2012-09-25REMS · Supplement 2AP
2012-08-29Labeling · Supplement 3 · 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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