Telmisartan

ANDA 203171, held by Torrent. Telmisartan.

As of Nov 14, 2026, ANDA 203171 (Telmisartan), held by Torrent, 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

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


Oct 8, 2026	Supplement 12Labeling · Standard review	Approved	None posted
Oct 8, 2026	Supplement 13Labeling · Standard review	Approved	None posted
Aug 7, 2019	Supplement 6Labeling · Standard review	Approved	None posted
Mar 2, 2015	Supplement 1Labeling · Standard review	Approved	None posted
Mar 2, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Jul 7, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 203171
Drugs@FDA: Overview at FDA
Company: Torrent 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