APPLICATION
ANDA203005
TYPE
ANDA
ORIGINAL APPROVAL
2014-11-14
LATEST ACTION
2026-07-29
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription
Products
MYCOPHENOLATE MOFETILPrescription
MYCOPHENOLATE MOFETIL 200MG/ML · FOR SUSPENSION · ORAL
Approval history
2026-07-29REMS · Supplement 23AP
2024-08-13REMS · Supplement 20AP
2023-05-08Labeling · Supplement 18 · standardAP
2022-03-08Labeling · Supplement 10 · standardAP
2021-08-11REMS · Supplement 17AP
2021-04-21REMS · Supplement 16AP
2021-01-15REMS · Supplement 13AP
2019-11-25Labeling · Supplement 8 · standardAP
2019-01-11Labeling · Supplement 6 · standardAP
2019-01-11Labeling · Supplement 4 · standardAP
2019-01-11Labeling · Supplement 7 · standardAP
2015-11-13REMS · Supplement 1AP
2015-11-06Labeling · Supplement 2 · 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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