Exforge Hct

Treats hypertension. NDA 22314, held by Novartis. Amlodipine Besylate; Hydrochlorothiazide; Valsartan.

As of Nov 14, 2026, NDA 22314 (Exforge Hct), held by Novartis, was first approved by FDA on Apr 30, 2009, with 17 approved supplements and 0 published complete response letters.

First approved: Apr 30, 2009
Review: Standard
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Exforge HCT (amlodipine, valsartan, and hydrochlorothiazide) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including amlodipine, hydrochlorothiazide, and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Exforge HCT.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Apr 30, 2009	Original applicationNew combination · Standard review	Approved	Summary Review Review Letter Label

Products

5 strengths and forms


Exforge HctEQ 5MG BASE;12.5MG;160MG · tablet;oral	Amlodipine Besylate; Hydrochlorothiazide; Valsartan	RxReference drug
Exforge HctEQ 5MG BASE;25MG;160MG · tablet;oral	Amlodipine Besylate; Hydrochlorothiazide; Valsartan	RxReference drug
Exforge HctEQ 10MG BASE;12.5MG;160MG · tablet;oral	Amlodipine Besylate; Hydrochlorothiazide; Valsartan	RxReference drug
Exforge HctEQ 10MG BASE;25MG;160MG · tablet;oral	Amlodipine Besylate; Hydrochlorothiazide; Valsartan	RxReference drug
Exforge HctEQ 10MG BASE;25MG;320MG · tablet;oral	Amlodipine Besylate; Hydrochlorothiazide; Valsartan	RxReference drug

All 18 submissions, including labeling and manufacturing supplements


Sep 26, 2022	Supplement 38Manufacturing	Approved	Label Letter
Feb 22, 2021	Supplement 36Labeling · Standard review	Approved	Label Letter
Aug 20, 2020	Supplement 35Labeling · Standard review	Approved	Letter Label
Jun 12, 2019	Supplement 27Labeling · Standard review	Approved	Letter Label
Feb 12, 2016	Supplement 22Manufacturing · Standard review	Approved	None posted
Jul 28, 2015	Supplement 20Labeling · Standard review	Approved	Letter Label
Sep 24, 2014	Supplement 19Labeling · Standard review	Approved	Label Letter
Jun 9, 2014	Supplement 17Manufacturing · Standard review	Approved	Label
Mar 17, 2014	Supplement 15Labeling · Standard review	Approved	Letter Label
Mar 17, 2014	Supplement 16Labeling · Standard review	Approved	Letter Label
Nov 28, 2012	Supplement 14Labeling · Standard review	Approved	Label Letter
Sep 28, 2012	Supplement 13Labeling	Approved	Letter Label
Feb 16, 2012	Supplement 9Labeling	Approved	Letter Label
Jan 18, 2012	Supplement 12Labeling	Approved	Letter
Dec 7, 2011	Supplement 7Labeling	Approved	Letter Label
Oct 31, 2011	Supplement 11Labeling	Approved	Letter Label
Jun 3, 2011	Supplement 5Labeling	Approved	Label Letter
Apr 30, 2009	Original applicationNew combination · Standard review	Approved	Summary Review Review Letter Label

Identifiers

Application: NDA 22314
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

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