Mavik

NDA 20528, held by Abbvie. Trandolapril.

As of Nov 13, 2026, NDA 20528 (Mavik), held by Abbvie, was first approved by FDA on Apr 26, 1996, with 19 approved supplements and 0 published complete response letters.

First approved: Apr 26, 1996
Review: Standard
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below


Jul 2, 1997	Supplement 1Efficacy (new indication or use)	Approved	Review
Apr 26, 1996	Original applicationNew molecular entity · Standard review	Approved	Review

Products

3 strengths and forms


Mavik1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Trandolapril	DiscontinuedReference drug
Mavik2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Trandolapril	DiscontinuedReference drug
Mavik4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Trandolapril	DiscontinuedReference drug

All 20 submissions, including labeling and manufacturing supplements


Aug 2, 2017	Supplement 25Labeling · Standard review	Approved	Label Letter
Jan 29, 2016	Supplement 24Labeling · Standard review	Approved	Label Letter
Dec 24, 2014	Supplement 23Labeling · Standard review	Approved	Label Letter
Jun 13, 2013	Supplement 22Manufacturing · Standard review	Approved	None posted
Sep 11, 2012	Supplement 21Labeling	Approved	Letter Label
Jan 23, 2012	Supplement 20Labeling	Approved	Label Letter
Jan 23, 2012	Supplement 18Labeling	Approved	Letter Label
Nov 10, 2011	Supplement 17Labeling	Approved	Letter
Sep 14, 2011	Supplement 19Labeling	Approved	Letter Label
Apr 20, 2010	Supplement 12Labeling · Standard review	Approved	Label Letter
Apr 8, 2009	Supplement 16Labeling · Standard review	Approved	Letter Label
Feb 6, 2004	Supplement 8Labeling · Standard review	Approved	Letter
Aug 20, 2002	Supplement 7Manufacturing · Standard review	Approved	None posted
Feb 2, 2001	Supplement 6Manufacturing · Standard review	Approved	None posted
Jul 14, 2000	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 5, 2000	Supplement 4Labeling · Standard review	Approved	None posted
Oct 26, 1999	Supplement 3Manufacturing · Standard review	Approved	None posted
Sep 24, 1999	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 2, 1997	Supplement 1Efficacy (new indication or use)	Approved	Review
Apr 26, 1996	Original applicationNew molecular entity · Standard review	Approved	Review

Identifiers

Application: NDA 20528
Drugs@FDA: Overview at FDA
Company: AbbVie

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