Trandolapril

Treats hypertension. ANDA 78438, held by Aurobindo Pharma. Trandolapril.

As of Nov 14, 2026, ANDA 78438 (Trandolapril), held by Aurobindo Pharma, was first approved by FDA on Jun 12, 2007, with 9 approved supplements and 0 published complete response letters.

First approved: Jun 12, 2007
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Hypertension Trandolapril tablets USP are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medication such as hydrochlorothiazide. Heart Failure Post Myocardial Infarction or Left-Ventricular Dysfunction Post Myocardial Infarction Trandolapril tablets USP are indicated in stable patients who have evidence of left-ventricular systolic dysfunction (identified by wall motion abnormalities) or who are symptomatic from congestive heart failure within the first few days after sustaining acute myocardial infarction.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Jun 12, 2007	Original application	Approved	None posted

Products

3 strengths and forms


Trandolapril1MG · tablet;oral	Trandolapril	Rx
Trandolapril2MG · tablet;oral	Trandolapril	Rx
Trandolapril4MG · tablet;oral	Trandolapril	Rx

All 10 submissions, including labeling and manufacturing supplements


Oct 1, 2019	Supplement 15Labeling · Standard review	Approved	None posted
Oct 1, 2019	Supplement 16Labeling · Standard review	Approved	None posted
Oct 30, 2015	Supplement 14Labeling · Standard review	Approved	None posted
Apr 24, 2015	Supplement 7Labeling	Approved	None posted
Apr 24, 2015	Supplement 8Labeling · Standard review	Approved	None posted
Apr 24, 2015	Supplement 12Labeling · Standard review	Approved	None posted
Nov 29, 2011	Supplement 6Labeling	Approved	None posted
Nov 29, 2010	Supplement 3Labeling	Approved	None posted
Jun 8, 2009	Supplement 2Labeling	Approved	None posted
Jun 12, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 78438
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma

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