Trandolapril

ANDA 78346, held by Pharmobedient. Trandolapril.

As of Nov 14, 2026, ANDA 78346 (Trandolapril), held by Pharmobedient, was first approved by FDA on Apr 28, 2008, with 4 approved supplements and 0 published complete response letters.

First approved: Apr 28, 2008
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Apr 28, 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 5 submissions, including labeling and manufacturing supplements


Apr 14, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Apr 14, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Apr 14, 2020	Supplement 5Labeling · Standard review	Approved	None posted
Aug 31, 2010	Supplement 2Labeling	Approved	None posted
Apr 28, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78346
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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