Tekturna Hct

NDA 22107, held by Noden Pharma. Aliskiren Hemifumarate; Hydrochlorothiazide.

As of Nov 14, 2026, NDA 22107 (Tekturna Hct), held by Noden Pharma, was first approved by FDA on Jan 18, 2008, with 19 approved supplements and 0 published complete response letters.

First approved: Jan 18, 2008
Review: Standard
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below


Jul 16, 2009	Supplement 2Efficacy (new indication or use)	Approved	Label Letter
Jan 18, 2008	Original applicationNew combination · Standard review	Approved	Review Summary Review Letter Label

Products

4 strengths and forms


Tekturna HctEQ 150MG BASE;12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Aliskiren Hemifumarate; Hydrochlorothiazide	DiscontinuedReference drug
Tekturna HctEQ 150MG BASE;25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Aliskiren Hemifumarate; Hydrochlorothiazide	DiscontinuedReference drug
Tekturna HctEQ 300MG BASE;12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Aliskiren Hemifumarate; Hydrochlorothiazide	DiscontinuedReference drug
Tekturna HctEQ 300MG BASE;25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Aliskiren Hemifumarate; Hydrochlorothiazide	DiscontinuedReference drug

All 20 submissions, including labeling and manufacturing supplements


Sep 28, 2020	Supplement 34Labeling · Standard review	Approved	Label Letter
Nov 4, 2016	Supplement 29Labeling · Standard review	Approved	Letter Label
Dec 22, 2015	Supplement 26Labeling · Standard review	Approved	Label Letter
Dec 21, 2015	Supplement 27Manufacturing · Standard review	Approved	None posted
Mar 27, 2015	Supplement 25Labeling · Standard review	Approved	Label Letter
Mar 18, 2014	Supplement 24Labeling · Standard review	Approved	Label
Nov 4, 2013	Supplement 23Labeling · Standard review	Approved	Letter Label
Sep 28, 2012	Supplement 22Labeling	Approved	Letter Label
Apr 16, 2012	Supplement 21Labeling	Approved	Letter Label
Feb 14, 2012	Supplement 16Labeling	Approved	Letter Label
Feb 2, 2012	Supplement 19Labeling	Approved	Letter
Jan 26, 2012	Supplement 17Labeling	Approved	Label Letter
Oct 12, 2011	Supplement 14Labeling	Approved	Label Letter
Jun 14, 2011	Supplement 13Labeling	Approved	Letter Label
Feb 10, 2011	Supplement 9Labeling	Approved	Letter Label
Aug 9, 2010	Supplement 7Labeling	Approved	Letter Label
May 22, 2010	Supplement 5Labeling	Approved	Label Letter
Jul 16, 2009	Supplement 2Efficacy (new indication or use)	Approved	Label Letter
Jul 17, 2008	Supplement 1Labeling · Standard review	Approved	Letter
Jan 18, 2008	Original applicationNew combination · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 22107
Drugs@FDA: Overview at FDA
Company: Noden Pharma

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters