← FDA DRUG APPROVALS

FDA NDA · NDA020591

TARKA

Sponsor: ABBVIE

APPLICATION
NDA020591
TYPE
NDA
ORIGINAL APPROVAL
1996-10-22
LATEST ACTION
2019-08-20
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

TARKA · ReferenceDiscontinued
TRANDOLAPRIL 1MG, VERAPAMIL HYDROCHLORIDE 240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
TARKA · ReferenceDiscontinued
TRANDOLAPRIL 2MG, VERAPAMIL HYDROCHLORIDE 180MG · TABLET, EXTENDED RELEASE · ORAL
TARKA · ReferenceDiscontinued
TRANDOLAPRIL 2MG, VERAPAMIL HYDROCHLORIDE 240MG · TABLET, EXTENDED RELEASE · ORAL
TARKA · ReferenceDiscontinued
TRANDOLAPRIL 4MG, VERAPAMIL HYDROCHLORIDE 240MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2019-08-20Labeling · Supplement 30 · standard — Letter ↗AP
2017-08-02Labeling · Supplement 29 · standard — Label ↗AP
2016-07-12Labeling · Supplement 27 · standard — Label ↗AP
2016-01-29Labeling · Supplement 26 · standard — Letter ↗AP
2015-01-05Manufacturing (CMC) · Supplement 24 · standardAP
2014-12-24Labeling · Supplement 25 · standard — Label ↗AP
2014-10-20Manufacturing (CMC) · Supplement 22 · standardAP
2012-09-12Labeling · Supplement 21 · unknown — Letter ↗AP
2012-01-23Labeling · Supplement 20 · unknown — Label ↗AP
2011-11-14Labeling · Supplement 19 · unknown — Letter ↗AP
2011-09-14Labeling · Supplement 18 · unknown — Letter ↗AP
2011-08-29Labeling · Supplement 12 · standard — Label ↗AP
2009-03-05Labeling · Supplement 16 · standard — Letter ↗AP
2008-02-29Labeling · Supplement 11 · standard — Letter ↗AP
2002-08-20Manufacturing (CMC) · Supplement 7 · standardAP
2002-05-31Manufacturing (CMC) · Supplement 6 · standardAP
2000-07-14Manufacturing (CMC) · Supplement 5 · standardAP
2000-03-01Manufacturing (CMC) · Supplement 4 · standardAP
1999-09-03Manufacturing (CMC) · Supplement 3 · standardAP
1997-10-22Manufacturing (CMC) · Supplement 1 · standardAP
1996-10-22Type 4 - New Combination · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →