← FDA DRUG APPROVALS

FDA NDA · NDA020552

COVERA-HS

Sponsor: PFIZER

APPLICATION
NDA020552
TYPE
NDA
ORIGINAL APPROVAL
1996-02-26
LATEST ACTION
2017-09-14
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

COVERA-HSDiscontinued
VERAPAMIL HYDROCHLORIDE 240MG · TABLET, EXTENDED RELEASE · ORAL
COVERA-HSDiscontinued
VERAPAMIL HYDROCHLORIDE 180MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2017-09-14Labeling · Supplement 10 · standard — Label ↗AP
2016-08-24Labeling · Supplement 9 · standard — Letter ↗AP
2011-11-02Labeling · Supplement 7 · unknown — Label ↗AP
2010-04-13Labeling · Supplement 6 · unknown — Letter ↗AP
2009-06-29Labeling · Supplement 5 · standard — Label ↗AP
2003-01-31Labeling · Supplement 2 · standard — Letter ↗AP
1998-01-13Labeling · Supplement 1 · standardAP
1996-02-26Type 5 - New Formulation or New Manufacturer · 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 →