← FDA DRUG APPROVALS

FDA NDA · NDA022107

TEKTURNA HCT

Sponsor: NODEN PHARMA

APPLICATION
NDA022107
TYPE
NDA
ORIGINAL APPROVAL
2008-01-18
LATEST ACTION
2020-09-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TEKTURNA HCT · ReferenceDiscontinued
ALISKIREN HEMIFUMARATE EQ 300MG BASE, HYDROCHLOROTHIAZIDE 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
TEKTURNA HCT · ReferenceDiscontinued
ALISKIREN HEMIFUMARATE EQ 150MG BASE, HYDROCHLOROTHIAZIDE 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
TEKTURNA HCT · ReferenceDiscontinued
ALISKIREN HEMIFUMARATE EQ 300MG BASE, HYDROCHLOROTHIAZIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
TEKTURNA HCT · ReferenceDiscontinued
ALISKIREN HEMIFUMARATE EQ 150MG BASE, HYDROCHLOROTHIAZIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2020-09-28Labeling · Supplement 34 · standard — Label ↗AP
2016-11-04Labeling · Supplement 29 · standard — Letter ↗AP
2015-12-22Labeling · Supplement 26 · standard — Label ↗AP
2015-12-21Manufacturing (CMC) · Supplement 27 · standardAP
2015-03-27Labeling · Supplement 25 · standard — Label ↗AP
2014-03-18Labeling · Supplement 24 · standard — Label ↗AP
2013-11-04Labeling · Supplement 23 · standard — Label ↗AP
2012-09-28Labeling · Supplement 22 · unknown — Letter ↗AP
2012-04-16Labeling · Supplement 21 · unknown — Label ↗AP
2012-02-14Labeling · Supplement 16 · unknown — Letter ↗AP
2012-02-02Labeling · Supplement 19 · unknown — Letter ↗AP
2012-01-26Labeling · Supplement 17 · unknown — Letter ↗AP
2011-10-12Labeling · Supplement 14 · unknown — Letter ↗AP
2011-06-14Labeling · Supplement 13 · unknown — Label ↗AP
2011-02-10Labeling · Supplement 9 · unknown — Label ↗AP
2010-08-09Labeling · Supplement 7 · unknown — Label ↗AP
2010-05-22Labeling · Supplement 5 · unknown — Label ↗AP
2009-07-16Efficacy · Supplement 2 · unknown — Letter ↗AP
2008-07-17Labeling · Supplement 1 · standard — Letter ↗AP
2008-01-18Type 4 - New Combination · Original · standard — Label ↗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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