Telmisartan

ANDA 205901, held by Hetero Labs Ltd V. Telmisartan.

As of Nov 14, 2026, ANDA 205901 (Telmisartan), held by Hetero Labs Ltd V, was first approved by FDA on Apr 22, 2016, with 3 approved supplements and 0 published complete response letters.

First approved: Apr 22, 2016
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Apr 22, 2016	Original application	Approved	Label Letter

Products

3 strengths and forms


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

All 4 submissions, including labeling and manufacturing supplements


Jul 16, 2020	Supplement 1Labeling · Standard review	Approved	None posted
Jul 16, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Jul 16, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Apr 22, 2016	Original application	Approved	Label Letter

Identifiers

Application: ANDA 205901
Drugs@FDA: Overview at FDA
Company: Hetero Labs Ltd

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