Telmisartan

ANDA 207016, held by Micro Labs. Telmisartan.

As of Nov 14, 2026, ANDA 207016 (Telmisartan), held by Micro Labs, was first approved by FDA on Oct 3, 2017, with 3 approved supplements and 0 published complete response letters.

First approved: Oct 3, 2017
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
Oct 3, 2017	Original application	Approved	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


Jun 8, 2023	Supplement 10Labeling · Standard review	Approved	None posted
Nov 4, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Nov 4, 2019	Supplement 4Labeling · Standard review	Approved	None posted
Oct 3, 2017	Original application	Approved	Letter

Identifiers

Application: ANDA 207016
Drugs@FDA: Overview at FDA
Company: Micro Labs Limited

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