Hydrochlorothiazide; Telmisartan

Treats hypertension. Sold as Micardis Hct. Every FDA application for this active ingredient: 1 branded and 10 generic.

As of Nov 15, 2026, FDA lists 11 applications for Hydrochlorothiazide; Telmisartan (sold as Micardis Hct), first approved Nov 17, 2000, with 0 new uses approved and 0 published complete response letters.

First approved: Nov 17, 2000
Applications: 11
New uses approved: 0
Complete response letters: 0

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

MICARDIS HCT 40-12.5 MG TABLET: $4.48 per unitBrand · 0% in a year
MICARDIS HCT 80-12.5 MG TABLET: $4.47 per unitBrand · 0% in a year
MICARDIS HCT 80-25 MG TABLET: $4.48 per unitBrand · 0% in a year

Clinical Trials

2 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Early Mineralocorticoid Receptor Antagonist Therapy for Low-Renin Essential HypertensionHypertension (HTN), Low-Renin Essential Hypertension · China National Center for Cardiovascular Diseases	Phase 4	Not yet recruiting	Nov 12, 2026
Study to Evaluate the Efficacy and Safety of TEL/AML/CTD in Elderly Patients With Essential HypertensionEssential Hypertension · Yuhan Corporation	Phase 4	Active, not recruiting	Sep 18, 2023

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Nov 17, 2000	Micardis HctNDA 21162 · New combination	Boehringer Ingelheim	15	Marketed
Feb 25, 2014	Telmisartan And HydrochlorothiazideANDA 91648	Natco	1	Discontinued
Feb 25, 2014	Telmisartan And HydrochlorothiazideANDA 201192	Torrent	3	Discontinued
Feb 25, 2014	Telmisartan And HydrochlorothiazideANDA 203010	Alembic	6	Marketed
Aug 7, 2014	Telmisartan And HydrochlorothiazideANDA 91351	Lupin	5	Discontinued
Nov 2, 2015	Telmisartan And HydrochlorothiazideANDA 204169	Macleods Pharms	5	Discontinued
Dec 15, 2016	Telmisartan And HydrochlorothiazideANDA 208727	Aurobindo Pharma	3	Marketed
Aug 15, 2017	Telmisartan And HydrochlorothiazideANDA 204221	Zydus Pharms	2	Marketed
Nov 6, 2017	Telmisartan And HydrochlorothiazideANDA 209028	Prinston	4	Marketed
Mar 4, 2019	Telmisartan And HydrochlorothiazideANDA 202544	Glenmark Pharms Ltd	2	Marketed
Mar 3, 2025	Telmisartan And HydrochlorothiazideANDA 218406	Mankind Pharma	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA