APPLICATION
ANDA214871
TYPE
ANDA
ORIGINAL APPROVAL
2021-11-02
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 13AP
2026-02-23Labeling · Supplement 11 · standardAP
2024-08-13REMS · Supplement 8AP
2022-12-21Labeling · Supplement 4 · standardAP
2022-12-21Labeling · 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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