APPLICATION
ANDA212634
TYPE
ANDA
ORIGINAL APPROVAL
2023-08-29
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
2026-04-10Labeling · Supplement 10 · standardAP
2024-08-13REMS · Supplement 3AP
2024-05-01Labeling · 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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