Telmisartan

Treats hypertension. ANDA 202397, held by Mylan. Telmisartan.

As of Nov 14, 2026, ANDA 202397 (Telmisartan), held by Mylan, was first approved by FDA on Jul 7, 2014, with 5 approved supplements and 0 published complete response letters.

First approved: Jul 7, 2014
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Telmisartan tablets are an angiotensin II receptor blocker (ARB) indicated for:

Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
Cardiovascular (CV) risk reduction in patients unable to take ACE inhibitors 1.1 Hypertension Telmisartan 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jul 7, 2014	Original application	Approved	None posted

Products

3 strengths and forms


Telmisartan20MG · tablet;oral	Telmisartan	Rx
Telmisartan40MG · tablet;oral	Telmisartan	Rx
Telmisartan80MG · tablet;oral	Telmisartan	Rx

All 6 submissions, including labeling and manufacturing supplements


Jul 14, 2023	Supplement 11Labeling · Standard review	Approved	None posted
Jul 14, 2023	Supplement 10Labeling · Standard review	Approved	None posted
May 17, 2019	Supplement 6Labeling · Standard review	Approved	None posted
Oct 19, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Sep 26, 2014	Supplement 1Labeling · Standard review	Approved	None posted
Jul 7, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 202397
Drugs@FDA: Overview at FDA
Company: Mylan

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