APPLICATION
ANDA205426
TYPE
ANDA
ORIGINAL APPROVAL
2021-03-05
LATEST ACTION
2026-03-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
EVEROLIMUSPrescription
EVEROLIMUS 7.5MG · TABLET · ORAL
EVEROLIMUSPrescription
EVEROLIMUS 2.5MG · TABLET · ORAL
EVEROLIMUSPrescription
EVEROLIMUS 10MG · TABLET · ORAL
EVEROLIMUSPrescription
EVEROLIMUS 5MG · TABLET · ORAL
Approval history
2026-03-06Labeling · Supplement 13 · standardAP
2023-06-22Manufacturing (CMC) · Supplement 9 · unknownAP
2023-06-22Labeling · Supplement 3 · standardAP
2023-06-22Labeling · Supplement 4 · standardAP
2021-03-05UNKNOWN · 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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