Telmisartan

Treats hypertension. ANDA 204415, held by Amneal Pharms. Telmisartan.

As of Nov 14, 2026, ANDA 204415 (Telmisartan), held by Amneal Pharms, was first approved by FDA on Sep 8, 2015, with 2 approved supplements and 0 published complete response letters.

First approved: Sep 8, 2015
Supplements approved: 2
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 3 submissions below

Date	Submission	Status	Documents
Sep 8, 2015	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 3 submissions, including labeling and manufacturing supplements


Jul 20, 2023	Supplement 15Labeling · Standard review	Approved	None posted
Nov 5, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Sep 8, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 204415
Drugs@FDA: Overview at FDA
Company: Amneal 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