Telmisartan And Hydrochlorothiazide

Treats hypertension. ANDA 203010, held by Alembic. Hydrochlorothiazide; Telmisartan.

As of Nov 15, 2026, ANDA 203010 (Telmisartan And Hydrochlorothiazide), held by Alembic, was first approved by FDA on Feb 25, 2014, with 6 approved supplements and 0 published complete response letters.

First approved: Feb 25, 2014
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Telmisartan and hydrochlorothiazide tablets are 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 telmisartan and hydrochlorothiazide tablets.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Feb 25, 2014	Original application	Approved	Letter

Products

3 strengths and forms


Telmisartan And Hydrochlorothiazide12.5MG;40MG · tablet;oral	Hydrochlorothiazide; Telmisartan	Rx
Telmisartan And Hydrochlorothiazide12.5MG;80MG · tablet;oral	Hydrochlorothiazide; Telmisartan	Rx
Telmisartan And Hydrochlorothiazide25MG;80MG · tablet;oral	Hydrochlorothiazide; Telmisartan	Rx

All 7 submissions, including labeling and manufacturing supplements


Sep 12, 2023	Supplement 28Labeling · Standard review	Approved	None posted
Jan 14, 2022	Supplement 19Labeling · Standard review	Approved	None posted
Nov 6, 2019	Supplement 11Labeling · Standard review	Approved	None posted
Mar 29, 2016	Supplement 1Labeling · Standard review	Approved	None posted
Mar 29, 2016	Supplement 2Labeling · Standard review	Approved	None posted
Mar 29, 2016	Supplement 4Labeling · Standard review	Approved	None posted
Feb 25, 2014	Original application	Approved	Letter

Identifiers

Application: ANDA 203010
Drugs@FDA: Overview at FDA
Company: Alembic, LLC

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