Micardis Hct

Treats hypertension. NDA 21162, held by Boehringer Ingelheim. Hydrochlorothiazide; Telmisartan.

As of Nov 14, 2026, NDA 21162 (Micardis Hct), held by Boehringer Ingelheim, was first approved by FDA on Nov 17, 2000, with 15 approved supplements and 0 published complete response letters.

First approved: Nov 17, 2000
Review: Standard
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

MICARDIS HCT (telmisartan 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 the classes to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with MICARDIS HCT.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Nov 17, 2000	Original applicationNew combination · Standard review	Approved	Review Letter Label

Products

3 strengths and forms


Micardis Hct12.5MG;40MG · tablet;oral	Hydrochlorothiazide; Telmisartan	RxReference drug
Micardis Hct12.5MG;80MG · tablet;oral	Hydrochlorothiazide; Telmisartan	RxReference drug
Micardis Hct25MG;80MG · tablet;oral	Hydrochlorothiazide; Telmisartan	RxReference drug

All 16 submissions, including labeling and manufacturing supplements


Dec 19, 2022	Supplement 47Labeling · Standard review	Approved	Letter Label
Aug 20, 2020	Supplement 45Labeling · Standard review	Approved	Label Letter
Feb 1, 2018	Supplement 40Labeling · Standard review	Approved	Label Letter
Jan 12, 2016	Supplement 32Labeling	Approved	Label Letter
Dec 12, 2014	Supplement 37Labeling · Standard review	Approved	Label Letter
Oct 24, 2012	Supplement 35Labeling · Standard review	Approved	Label Letter
Jan 20, 2012	Supplement 30Labeling	Approved	Letter Label
Jan 19, 2012	Supplement 34Labeling	Approved	Letter Label
May 12, 2011	Supplement 31Labeling	Approved	Label Letter
May 12, 2011	Supplement 29Labeling	Approved	Label Letter
Aug 11, 2009	Supplement 20Labeling · Standard review	Approved	Letter Label
Aug 11, 2009	Supplement 19Labeling · Standard review	Approved	Letter Label
Feb 27, 2007	Supplement 16Labeling · Standard review	Approved	Letter
Sep 2, 2005	Supplement 8Labeling · Standard review	Approved	Letter Label
Apr 19, 2004	Supplement 5Manufacturing · Standard review	Approved	Letter
Nov 17, 2000	Original applicationNew combination · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21162
Drugs@FDA: Overview at FDA
Company: Boehringer Ingelheim Pharmaceuticals, Inc.

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