Trandolapril

ANDA 78493, held by Pharmazone. Trandolapril.

As of Nov 14, 2026, ANDA 78493 (Trandolapril), held by Pharmazone, was first approved by FDA on Aug 25, 2008, with 3 approved supplements and 0 published complete response letters.

First approved: Aug 25, 2008
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
Aug 25, 2008	Original application	Approved	None posted

Products

3 strengths and forms


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

All 4 submissions, including labeling and manufacturing supplements


Jun 30, 2015	Supplement 2Labeling	Approved	None posted
Jun 30, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Jun 8, 2009	Supplement 1Labeling	Approved	None posted
Aug 25, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78493
Drugs@FDA: Overview at FDA
Company: Pharmazone

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