Telmisartan And Hydrochlorothiazide

ANDA 201192, held by Torrent. Hydrochlorothiazide; Telmisartan.

As of Nov 15, 2026, ANDA 201192 (Telmisartan And Hydrochlorothiazide), held by Torrent, was first approved by FDA on Feb 25, 2014, with 3 approved supplements and 0 published complete response letters.

First approved: Feb 25, 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
Feb 25, 2014	Original application	Approved	Letter

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 4 submissions, including labeling and manufacturing supplements


Nov 6, 2019	Supplement 6Labeling · Standard review	Approved	None posted
Mar 24, 2016	Supplement 2Labeling · Standard review	Approved	None posted
Mar 24, 2016	Supplement 3Labeling · Standard review	Approved	None posted
Feb 25, 2014	Original application	Approved	Letter

Identifiers

Application: ANDA 201192
Drugs@FDA: Overview at FDA
Company: Torrent 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