APPLICATION
ANDA218227
TYPE
ANDA
ORIGINAL APPROVAL
2024-09-26
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 4AP
2026-03-18Labeling · Supplement 1 · standardAP
2024-09-26UNKNOWN · Original · 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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