← FDA DRUG APPROVALS

FDA NDA · NDA021268

TEVETEN HCT

Sponsor: ABBVIE

APPLICATION
NDA021268
TYPE
NDA
ORIGINAL APPROVAL
2001-11-01
LATEST ACTION
2014-07-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TEVETEN HCTDiscontinued
EPROSARTAN MESYLATE 600MG, HYDROCHLOROTHIAZIDE 12.5MG · TABLET · ORAL
TEVETEN HCTDiscontinued
EPROSARTAN MESYLATE 600MG, HYDROCHLOROTHIAZIDE 25MG · TABLET · ORAL

Approval history

2014-07-22Labeling · Supplement 19 · standard — Label ↗AP
2012-09-12Labeling · Supplement 18 · unknown — Letter ↗AP
2012-01-19Labeling · Supplement 17 · unknown — Letter ↗AP
2011-05-19Labeling · Supplement 15 · unknown — Letter ↗AP
2011-05-19Labeling · Supplement 16 · unknown — Letter ↗AP
2005-07-11Manufacturing (CMC) · Supplement 9 · standard — Letter ↗AP
2003-10-16Labeling · Supplement 2 · standard — Letter ↗AP
2003-07-07Manufacturing (CMC) · Supplement 6 · standard — Letter ↗AP
2002-09-27Manufacturing (CMC) · Supplement 1 · standardAP
2001-11-01Type 4 - New Combination · Original · standard — Review ↗AP
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 →