← FDA DRUG APPROVALS

FDA NDA · NDA021985

ALISKIREN

aliskiren hemifumarate

Sponsor: LXO IRELAND

APPLICATION
NDA021985
TYPE
NDA
ORIGINAL APPROVAL
2007-03-05
LATEST ACTION
2020-06-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TEKTURNA · ReferencePrescription
ALISKIREN HEMIFUMARATE EQ 300MG BASE · TABLET · ORAL
TEKTURNA · ReferencePrescription
ALISKIREN HEMIFUMARATE EQ 150MG BASE · TABLET · ORAL

Approval history

2020-06-17Labeling · Supplement 39 · standard — Letter ↗AP
2017-11-14Labeling · Supplement 34 · standard — Letter ↗AP
2016-11-04Labeling · Supplement 31 · standard — Letter ↗AP
2015-12-22Labeling · Supplement 28 · standard — Letter ↗AP
2015-03-27Labeling · Supplement 27 · standard — Letter ↗AP
2014-03-18Labeling · Supplement 26 · standard — Label ↗AP
2013-11-04Labeling · Supplement 25 · standard — Label ↗AP
2012-09-28Labeling · Supplement 24 · unknown — Label ↗AP
2012-04-16Labeling · Supplement 23 · unknown — Label ↗AP
2012-02-02Labeling · Supplement 22 · unknown — Label ↗AP
2012-01-26Labeling · Supplement 21 · unknown — Label ↗AP
2011-10-12Labeling · Supplement 19 · unknown — Letter ↗AP
2011-02-10Labeling · Supplement 14 · unknown — Label ↗AP
2010-08-04Labeling · Supplement 12 · unknown — Letter ↗AP
2009-11-10Labeling · Supplement 8 · standard — Letter ↗AP
2008-05-19Labeling · Supplement 6 · standard — Letter ↗AP
2008-02-15Labeling · Supplement 4 · standard — Letter ↗AP
2007-08-07Labeling · Supplement 2 · standard — Letter ↗AP
2007-03-05Type 1 - New Molecular Entity · Original · standard — 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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