APPLICATION
ANDA217031
TYPE
ANDA
ORIGINAL APPROVAL
2023-11-29
LATEST ACTION
2026-07-29
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
MYCOPHENOLATE SODIUMPrescription
MYCOPHENOLATE SODIUM EQ 360MG BASE · TABLET, DELAYED RELEASE · ORAL
MYCOPHENOLATE SODIUMPrescription
MYCOPHENOLATE SODIUM EQ 180MG BASE · TABLET, DELAYED RELEASE · ORAL
Approval history
2026-07-29REMS · Supplement 3AP
2024-08-13REMS · Supplement 1AP
2023-11-29UNKNOWN · 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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