← FDA DRUG APPROVALS

FDA NDA · NDA021560

ZORTRESS

everolimus

Sponsor: NOVARTIS

APPLICATION
NDA021560
TYPE
NDA
ORIGINAL APPROVAL
2010-04-20
LATEST ACTION
2024-02-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ZORTRESS · ReferencePrescription
EVEROLIMUS 1MG · TABLET · ORAL
ZORTRESS · ReferencePrescription
EVEROLIMUS 0.5MG · TABLET · ORAL
ZORTRESS · ReferencePrescription
EVEROLIMUS 0.75MG · TABLET · ORAL
ZORTRESS · ReferencePrescription
EVEROLIMUS 0.25MG · TABLET · ORAL

Approval history

2024-02-28Labeling · Supplement 32 · standard — Label ↗AP
2023-09-14Labeling · Supplement 33 · standard — Letter ↗AP
2023-04-13Manufacturing (CMC) · Supplement 31 — Letter ↗AP
2018-08-10Manufacturing (CMC) · Supplement 22 · standard — Letter ↗AP
2018-01-12Labeling · Supplement 20 · standard — Letter ↗AP
2018-01-12Labeling · Supplement 21 · standard — Label ↗AP
2016-10-12Efficacy · Supplement 19 · standard — Letter ↗AP
2016-03-01Manufacturing (CMC) · Supplement 17 · standardAP
2015-11-05Labeling · Supplement 18 · 901 order — Label ↗AP
2015-06-24Manufacturing (CMC) · Supplement 14 · standardAP
2015-01-27Labeling · Supplement 11 · standard — Letter ↗AP
2013-12-05Manufacturing (CMC) · Supplement 12 · standardAP
2013-11-14Manufacturing (CMC) · Supplement 13 · standardAP
2013-03-26Manufacturing (CMC) · Supplement 10 · standardAP
2013-02-15Efficacy · Supplement 6 · standard — Letter ↗AP
2012-10-02Labeling · Supplement 8 · standard — Label ↗AP
2012-05-02REMS · Supplement 9 — Letter ↗AP
2012-04-26Labeling · Supplement 7 · standard — Label ↗AP
2011-11-21REMS · Supplement 4 — Letter ↗AP
2010-04-20Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →