← FDA DRUG APPROVALS

FDA NDA · NDA203985

AFINITOR DISPERZ

everolimus

Sponsor: NOVARTIS PHARM

APPLICATION
NDA203985
TYPE
NDA
ORIGINAL APPROVAL
2012-08-29
LATEST ACTION
2026-06-01
ROUTE
ORAL
DOSAGE FORM
TABLET, FOR SUSPENSION
MARKETING STATUS
Prescription

Products

AFINITOR DISPERZ · ReferencePrescription
EVEROLIMUS 3MG · TABLET, FOR SUSPENSION · ORAL
AFINITOR DISPERZ · ReferencePrescription
EVEROLIMUS 5MG · TABLET, FOR SUSPENSION · ORAL
AFINITOR DISPERZ · ReferencePrescription
EVEROLIMUS 2MG · TABLET, FOR SUSPENSION · ORAL

Approval history

2026-06-01Labeling · Supplement 28 · standard — Label ↗AP
2024-03-11Manufacturing (CMC) · Supplement 27 — Letter ↗AP
2022-02-01Labeling · Supplement 23 · standard — Letter ↗AP
2021-04-16Labeling · Supplement 20 · standard — Label ↗AP
2020-02-13Labeling · Supplement 16 · standard — Label ↗AP
2020-01-22Labeling · Supplement 17 · standard — Letter ↗AP
2018-04-10Efficacy · Supplement 13 · standard — Label ↗AP
2016-01-29Efficacy · Supplement 10 · standard — Label ↗AP
2015-08-24Manufacturing (CMC) · Supplement 9 · priorityAP
2015-07-01Manufacturing (CMC) · Supplement 6 · priorityAP
2015-01-23Labeling · Supplement 8 · standard — Letter ↗AP
2014-07-01Labeling · Supplement 7 · standard — Letter ↗AP
2014-02-20Labeling · Supplement 4 · standard — Label ↗AP
2014-02-20Labeling · Supplement 2 · standard — Label ↗AP
2014-02-20Labeling · Supplement 5 · standard — Label ↗AP
2013-11-06Efficacy · Supplement 3 · standard — Label ↗AP
2013-03-26Manufacturing (CMC) · Supplement 1 · priorityAP
2012-08-29Type 3 - New Dosage Form · Original · priority — Summary Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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