APPLICATION
ANDA091248
TYPE
ANDA
ORIGINAL APPROVAL
2014-01-08
LATEST ACTION
2026-07-29
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued
Products
MYCOPHENOLATE SODIUMDiscontinued
MYCOPHENOLATE SODIUM EQ 360MG BASE · TABLET, DELAYED RELEASE · ORAL
MYCOPHENOLATE SODIUMDiscontinued
MYCOPHENOLATE SODIUM EQ 180MG BASE · TABLET, DELAYED RELEASE · ORAL
Approval history
2026-07-29REMS · Supplement 22AP
2024-08-13REMS · Supplement 20AP
2021-08-11REMS · Supplement 17AP
2021-04-21REMS · Supplement 15AP
2021-01-15REMS · Supplement 14AP
2015-11-13REMS · Supplement 3AP
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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