APPLICATION
ANDA205432
TYPE
ANDA
ORIGINAL APPROVAL
2021-05-20
LATEST ACTION
2025-03-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
EVEROLIMUSPrescription
EVEROLIMUS 0.75MG · TABLET · ORAL
EVEROLIMUSPrescription
EVEROLIMUS 0.25MG · TABLET · ORAL
EVEROLIMUSPrescription
EVEROLIMUS 1MG · TABLET · ORAL
EVEROLIMUSPrescription
EVEROLIMUS 0.5MG · TABLET · ORAL
Approval history
2025-03-24Labeling · Supplement 10 · standardAP
2025-03-24Labeling · Supplement 11 · standardAP
2024-02-05Manufacturing (CMC) · Supplement 7 · unknownAP
2021-05-20UNKNOWN · 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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