APPLICATION
ANDA210130
TYPE
ANDA
ORIGINAL APPROVAL
2019-04-19
LATEST ACTION
2024-02-23
ROUTE
ORAL
DOSAGE FORM
TABLET, FOR SUSPENSION
MARKETING STATUS
Discontinued
Products
EVEROLIMUSDiscontinued
EVEROLIMUS 5MG · TABLET, FOR SUSPENSION · ORAL
EVEROLIMUSDiscontinued
EVEROLIMUS 2MG · TABLET, FOR SUSPENSION · ORAL
EVEROLIMUSDiscontinued
EVEROLIMUS 3MG · TABLET, FOR SUSPENSION · ORAL
Approval history
2024-02-23Labeling · Supplement 7 · standardAP
2021-08-25Manufacturing (CMC) · Supplement 3 · unknownAP
2021-02-23Labeling · Supplement 2 · 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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