← FDA DRUG APPROVALS

FDA NDA · NDA022068

TASIGNA

nilotinib

Sponsor: NOVARTIS

APPLICATION
NDA022068
TYPE
NDA
ORIGINAL APPROVAL
2007-10-29
LATEST ACTION
2024-08-14
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

TASIGNA · ReferencePrescription
NILOTINIB HYDROCHLORIDE EQ 150MG BASE · CAPSULE · ORAL
TASIGNA · ReferencePrescription
NILOTINIB HYDROCHLORIDE EQ 50MG BASE · CAPSULE · ORAL
TASIGNA · ReferencePrescription
NILOTINIB HYDROCHLORIDE EQ 200MG BASE · CAPSULE · ORAL

Approval history

2024-08-14Labeling · Supplement 42 · standard — Letter ↗AP
2024-02-29Manufacturing (CMC) · Supplement 40 — Letter ↗AP
2024-02-08Labeling · Supplement 41 · standard — Letter ↗AP
2024-02-06Manufacturing (CMC) · Supplement 39 — Label ↗AP
2022-02-18Manufacturing (CMC) · Supplement 37 · standard — Letter ↗AP
2021-09-23Efficacy · Supplement 35 · priority — Label ↗AP
2021-09-23Efficacy · Supplement 36 · priority — Label ↗AP
2020-12-08Labeling · Supplement 33 · standard — Letter ↗AP
2019-09-25Labeling · Supplement 31 · standard — Letter ↗AP
2018-08-21Labeling · Supplement 29 · standard — Label ↗AP
2018-03-22Efficacy · Supplement 27 · priority — Label ↗AP
2017-12-22Efficacy · Supplement 26 · priority — Label ↗AP
2017-02-21Labeling · Supplement 24 · standard — Letter ↗AP
2016-09-27Labeling · Supplement 23 · standard — Label ↗AP
2015-10-15Labeling · Supplement 21 · standard — Label ↗AP
2015-01-27Efficacy · Supplement 20 · standard — Label ↗AP
2014-09-25Labeling · Supplement 19 · standard — Label ↗AP
2014-01-22Efficacy · Supplement 17 · standard — Label ↗AP
2013-09-27Labeling · Supplement 18 · unknown — Label ↗AP
2013-08-14Manufacturing (CMC) · Supplement 15 · standardAP
2013-06-13Labeling · Supplement 14 · standard — Label ↗AP
2013-05-22REMS · Supplement 16 — Letter ↗AP
2013-05-17Labeling · Supplement 13 · standard — Letter ↗AP
2012-12-20Efficacy · Supplement 11 · standard — Letter ↗AP
2012-05-01Labeling · Supplement 12 · standard — Letter ↗AP
2011-11-18Efficacy · Supplement 8 · standard — Label ↗AP
2011-11-18Labeling · Supplement 9 · unknown — Label ↗AP
2011-10-26Labeling · Supplement 7 · unknown — Label ↗AP
2011-01-14Efficacy · Supplement 6 · standard — Label ↗AP
2010-06-17Labeling · Supplement 4 · unknown — Label ↗AP
2010-06-17Efficacy · Supplement 5 · priority — Letter ↗AP
2010-03-15Labeling · Supplement 1 · standard — Letter ↗AP
2009-08-21Labeling · Supplement 2 · standard — Letter ↗AP
2007-10-29Type 1 - New Molecular Entity · Original · standard — 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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