Micardis

NDA 20850, held by Boehringer Ingelheim. Telmisartan.

As of Nov 13, 2026, NDA 20850 (Micardis), held by Boehringer Ingelheim, was first approved by FDA on Nov 10, 1998, with 21 approved supplements and 0 published complete response letters.

First approved: Nov 10, 1998
Review: Standard
Supplements approved: 21
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below


Oct 16, 2009	Supplement 25Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 10, 1998	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

3 strengths and forms


Micardis40MG · tablet;oral	Telmisartan	DiscontinuedReference drug
Micardis80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Telmisartan	DiscontinuedReference drug
Micardis20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Telmisartan	DiscontinuedReference drug

All 22 submissions, including labeling and manufacturing supplements


Dec 19, 2022	Supplement 45Labeling · Standard review	Approved	Letter Label
Feb 1, 2018	Supplement 40Labeling · Standard review	Approved	Label Letter
Aug 5, 2015	Supplement 39Manufacturing · Standard review	Approved	None posted
Feb 16, 2015	Supplement 37Manufacturing · Standard review	Approved	None posted
Dec 12, 2014	Supplement 38Labeling · Standard review	Approved	Letter Label
Oct 24, 2012	Supplement 36Labeling · Standard review	Approved	Letter Label
Sep 20, 2012	Supplement 33Labeling	Approved	Letter Label
Jan 19, 2012	Supplement 35Labeling	Approved	Label Letter
Jan 18, 2012	Supplement 31Labeling	Approved	Letter Label
Jul 6, 2011	Supplement 32Labeling	Approved	Label Letter
Oct 16, 2009	Supplement 25Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 11, 2009	Supplement 23Labeling · Standard review	Approved	Letter Label
Aug 11, 2009	Supplement 22Labeling · Standard review	Approved	Letter Label
Feb 27, 2007	Supplement 19Labeling · Standard review	Approved	Letter
Sep 2, 2005	Supplement 13Labeling · Standard review	Approved	Label Letter
Mar 30, 2004	Supplement 11Labeling · Standard review	Approved	Label Letter
Oct 23, 2003	Supplement 5Labeling · Standard review	Approved	Letter
Oct 12, 2000	Supplement 4Manufacturing · Standard review	Approved	None posted
Apr 4, 2000	Supplement 3Manufacturing · Standard review	Approved	None posted
Dec 2, 1999	Supplement 2Manufacturing · Standard review	Approved	None posted
Oct 29, 1999	Supplement 1Manufacturing · Standard review	Approved	None posted
Nov 10, 1998	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 20850
Drugs@FDA: Overview at FDA
Company: Boehringer Ingelheim Pharmaceuticals, Inc.

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