Telmisartan And Hydrochlorothiazide

ANDA 91648, held by Natco. Hydrochlorothiazide; Telmisartan.

As of Nov 15, 2026, ANDA 91648 (Telmisartan And Hydrochlorothiazide), held by Natco, was first approved by FDA on Feb 25, 2014, with 1 approved supplement and 0 published complete response letters.

First approved: Feb 25, 2014
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 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 2 submissions, including labeling and manufacturing supplements


Oct 26, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Feb 25, 2014	Original application	Approved	Letter

Identifiers

Application: ANDA 91648
Drugs@FDA: Overview at FDA
Company: Natco Corp.

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