Trandolapril

ANDA 78320, held by Invagen Pharms. Trandolapril.

As of Nov 14, 2026, ANDA 78320 (Trandolapril), held by Invagen Pharms, was first approved by FDA on Jun 12, 2007, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 12, 2007
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
Jun 12, 2007	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 2 submissions, including labeling and manufacturing supplements


Jun 10, 2013	Supplement 1Labeling	Approved	None posted
Jun 12, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 78320
Drugs@FDA: Overview at FDA
Company: InvaGen Pharmaceuticals, Inc.

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