APPLICATION
ANDA212936
TYPE
ANDA
ORIGINAL APPROVAL
2020-06-08
LATEST ACTION
2024-10-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
EVEROLIMUSDiscontinued
EVEROLIMUS 7.5MG · TABLET · ORAL
EVEROLIMUSDiscontinued
EVEROLIMUS 2.5MG · TABLET · ORAL
EVEROLIMUSDiscontinued
EVEROLIMUS 10MG · TABLET · ORAL
EVEROLIMUSDiscontinued
EVEROLIMUS 5MG · TABLET · ORAL
Approval history
2024-10-09Labeling · Supplement 7 · standardAP
2024-10-09Labeling · Supplement 8 · standardAP
2024-10-09Labeling · Supplement 6 · standardAP
2020-06-08UNKNOWN · 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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