Trandolapril

ANDA 77489, held by Teva Pharms. Trandolapril.

As of Nov 14, 2026, ANDA 77489 (Trandolapril), held by Teva Pharms, was first approved by FDA on Dec 12, 2006, with 7 approved supplements and 0 published complete response letters.

First approved: Dec 12, 2006
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Dec 12, 2006	Original application	Approved	Letter

Products

3 strengths and forms


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

All 8 submissions, including labeling and manufacturing supplements


Aug 31, 2015	Supplement 6Labeling	Approved	None posted
Aug 31, 2015	Supplement 7Labeling · Standard review	Approved	None posted
Aug 31, 2015	Supplement 8Labeling · Standard review	Approved	None posted
Aug 31, 2015	Supplement 10Labeling · Standard review	Approved	None posted
Jul 6, 2010	Supplement 5Labeling	Approved	None posted
Dec 11, 2009	Supplement 4Labeling	Approved	None posted
May 25, 2007	Supplement 2Labeling	Approved	None posted
Dec 12, 2006	Original application	Approved	Letter

Identifiers

Application: ANDA 77489
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals

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