Tarka

NDA 20591, held by Abbvie. Trandolapril; Verapamil Hydrochloride.

As of Nov 14, 2026, NDA 20591 (Tarka), held by Abbvie, was first approved by FDA on Oct 22, 1996, with 20 approved supplements and 0 published complete response letters.

First approved: Oct 22, 1996
Review: Standard
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Oct 22, 1996	Original applicationNew combination · Standard review	Approved	None posted

Products

4 strengths and forms


Tarka2MG;180MG · tablet, extended release;oral	Trandolapril; Verapamil Hydrochloride	DiscontinuedReference drug
Tarka4MG;240MG · tablet, extended release;oral	Trandolapril; Verapamil Hydrochloride	DiscontinuedReference drug
Tarka1MG;240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Trandolapril; Verapamil Hydrochloride	DiscontinuedReference drug
Tarka2MG;240MG · tablet, extended release;oral	Trandolapril; Verapamil Hydrochloride	DiscontinuedReference drug

All 21 submissions, including labeling and manufacturing supplements


Aug 20, 2019	Supplement 30Labeling · Standard review	Approved	Label Letter
Aug 2, 2017	Supplement 29Labeling · Standard review	Approved	Label Letter
Jul 12, 2016	Supplement 27Labeling · Standard review	Approved	Label Letter
Jan 29, 2016	Supplement 26Labeling · Standard review	Approved	Label Letter
Jan 5, 2015	Supplement 24Manufacturing · Standard review	Approved	None posted
Dec 24, 2014	Supplement 25Labeling · Standard review	Approved	Label Letter
Oct 20, 2014	Supplement 22Manufacturing · Standard review	Approved	None posted
Sep 12, 2012	Supplement 21Labeling	Approved	Letter Label
Jan 23, 2012	Supplement 20Labeling	Approved	Letter Label
Nov 14, 2011	Supplement 19Labeling	Approved	Letter Label
Sep 14, 2011	Supplement 18Labeling	Approved	Letter Label
Aug 29, 2011	Supplement 12Labeling · Standard review	Approved	Letter Label
Mar 5, 2009	Supplement 16Labeling · Standard review	Approved	Letter
Feb 29, 2008	Supplement 11Labeling · Standard review	Approved	Letter
Aug 20, 2002	Supplement 7Manufacturing · Standard review	Approved	None posted
May 31, 2002	Supplement 6Manufacturing · Standard review	Approved	None posted
Jul 14, 2000	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 1, 2000	Supplement 4Manufacturing · Standard review	Approved	None posted
Sep 3, 1999	Supplement 3Manufacturing · Standard review	Approved	None posted
Oct 22, 1997	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 22, 1996	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 20591
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