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FDA NDA · NDA205755

ZYKADIA

Sponsor: NOVARTIS

APPLICATION
NDA205755
TYPE
NDA
ORIGINAL APPROVAL
2014-04-29
LATEST ACTION
2021-10-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

ZYKADIA · ReferenceDiscontinued
CERITINIB 150MG · CAPSULE · ORAL

Approval history

2021-10-07Labeling · Supplement 19 · standard — Letter ↗AP
2021-08-19Labeling · Supplement 18 · standard — Label ↗AP
2019-03-05Labeling · Supplement 16 · standard — Letter ↗AP
2017-12-21Efficacy · Supplement 10 · standard — Label ↗AP
2017-11-20Labeling · Supplement 11 · standard — Label ↗AP
2017-07-19Labeling · Supplement 12 · standard — Label ↗AP
2017-05-26Efficacy · Supplement 9 · priority — Letter ↗AP
2016-09-07Labeling · Supplement 6 · standard — Label ↗AP
2015-08-25Manufacturing (CMC) · Supplement 5 · priorityAP
2015-07-22Labeling · Supplement 3 · standard — Letter ↗AP
2015-07-22Labeling · Supplement 4 · standard — Label ↗AP
2015-06-24Manufacturing (CMC) · Supplement 2 · priorityAP
2014-10-30Manufacturing (CMC) · Supplement 1 · priorityAP
2014-04-29Type 1 - New Molecular Entity · Original · priority — Review ↗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.

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