APPLICATION
ANDA218488
TYPE
ANDA
ORIGINAL APPROVAL
2026-05-12
LATEST ACTION
2026-05-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
EVEROLIMUSPrescription
EVEROLIMUS 10MG · TABLET · ORAL
EVEROLIMUSPrescription
EVEROLIMUS 5MG · TABLET · ORAL
EVEROLIMUSPrescription
EVEROLIMUS 7.5MG · TABLET · ORAL
EVEROLIMUSPrescription
EVEROLIMUS 2.5MG · TABLET · ORAL
Approval history
2026-05-12UNKNOWN · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.