Telmisartan And Hydrochlorothiazide

ANDA 204169, held by Macleods Pharms. Hydrochlorothiazide; Telmisartan.

As of Nov 15, 2026, ANDA 204169 (Telmisartan And Hydrochlorothiazide), held by Macleods Pharms, was first approved by FDA on Nov 2, 2015, with 5 approved supplements and 0 published complete response letters.

First approved: Nov 2, 2015
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
Nov 2, 2015	Original application	Approved	None posted

Products

3 strengths and forms


Telmisartan And Hydrochlorothiazide12.5MG;40MG · tablet;oral	Hydrochlorothiazide; Telmisartan	Discontinued
Telmisartan And Hydrochlorothiazide12.5MG;80MG · tablet;oral	Hydrochlorothiazide; Telmisartan	Discontinued
Telmisartan And Hydrochlorothiazide25MG;80MG · tablet;oral	Hydrochlorothiazide; Telmisartan	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Mar 21, 2025	Supplement 25Labeling · Standard review	Approved	None posted
Jun 7, 2023	Supplement 23Labeling · Standard review	Approved	None posted
Dec 10, 2021	Supplement 18Labeling · Standard review	Approved	None posted
Nov 6, 2019	Supplement 7Labeling · Standard review	Approved	None posted
Nov 21, 2016	Supplement 1Labeling · Standard review	Approved	None posted
Nov 2, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 204169
Drugs@FDA: Overview at FDA
Company: Macleods 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