Trandolapril

ANDA 77805, held by Watson Labs. Trandolapril.

As of Nov 14, 2026, ANDA 77805 (Trandolapril), held by Watson Labs, was first approved by FDA on Jun 12, 2007, with 4 approved supplements and 0 published complete response letters.

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


May 6, 2025	Supplement 10Labeling · Standard review	Approved	None posted
Jun 22, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Jun 22, 2015	Supplement 9Labeling · Standard review	Approved	None posted
Apr 29, 2010	Supplement 3Labeling	Approved	None posted
Jun 12, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 77805
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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