Telmisartan

ANDA 203867, held by Sandoz. Telmisartan.

As of Nov 14, 2026, ANDA 203867 (Telmisartan), held by Sandoz, was first approved by FDA on Nov 3, 2014, with 3 approved supplements and 0 published complete response letters.

First approved: Nov 3, 2014
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
Nov 3, 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 4 submissions, including labeling and manufacturing supplements


May 17, 2019	Supplement 7Labeling · Standard review	Approved	None posted
Nov 17, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Nov 17, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Nov 3, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 203867
Drugs@FDA: Overview at FDA
Company: Sandoz

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