Telmisartan

Treats hypertension. ANDA 208605, held by Cadila Pharms Ltd. Telmisartan.

As of Nov 14, 2026, ANDA 208605 (Telmisartan), held by Cadila Pharms Ltd, was first approved by FDA on Jul 25, 2017, with 2 approved supplements and 0 published complete response letters.

First approved: Jul 25, 2017
Review: Standard
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

SECTION Telmisartan is 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, USP 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 3 submissions below

Date	Submission	Status	Documents
Jul 25, 2017	Original application	Approved	Letter

Products

3 strengths and forms


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

All 3 submissions, including labeling and manufacturing supplements


Dec 21, 2023	Supplement 7Manufacturing	Approved	None posted
May 17, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Jul 25, 2017	Original application	Approved	Letter

Identifiers

Application: ANDA 208605
Drugs@FDA: Overview at FDA
Company: Cadila Pharmaceuticals

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