← FDA DRUG APPROVALS

FDA ANDA · ANDA073568

VERAPAMIL HYDROCHLORIDE

Sponsor: IVAX SUB TEVA PHARMS

APPLICATION
ANDA073568
TYPE
ANDA
ORIGINAL APPROVAL
1992-07-31
LATEST ACTION
2012-03-30
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

VERAPAMIL HYDROCHLORIDEDiscontinued
VERAPAMIL HYDROCHLORIDE 240MG · TABLET, EXTENDED RELEASE · ORAL
VERAPAMIL HYDROCHLORIDEDiscontinued
VERAPAMIL HYDROCHLORIDE 120MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2012-03-30Labeling · Supplement 67AP
2010-04-28Labeling · Supplement 65AP
2009-09-18Labeling · Supplement 61AP
2002-12-09Manufacturing (CMC) · Supplement 49AP
2002-09-05Manufacturing (CMC) · Supplement 48AP
2002-05-15Manufacturing (CMC) · Supplement 38AP
2002-05-15Manufacturing (CMC) · Supplement 40AP
2002-03-26Manufacturing (CMC) · Supplement 47AP
2001-09-12Manufacturing (CMC) · Supplement 46AP
2001-06-07Manufacturing (CMC) · Supplement 35AP
2001-03-21Manufacturing (CMC) · Supplement 41AP
2001-02-06Manufacturing (CMC) · Supplement 45AP
2000-11-28Manufacturing (CMC) · Supplement 43AP
2000-10-06Labeling · Supplement 37AP
2000-10-06Manufacturing (CMC) · Supplement 31AP
2000-10-06Manufacturing (CMC) · Supplement 32AP
2000-10-06Manufacturing (CMC) · Supplement 30AP
2000-08-14Manufacturing (CMC) · Supplement 36AP
2000-08-14Manufacturing (CMC) · Supplement 42AP
2000-06-29Manufacturing (CMC) · Supplement 33AP
2000-06-16Manufacturing (CMC) · Supplement 34AP
1999-07-01Manufacturing (CMC) · Supplement 27AP
1999-07-01Manufacturing (CMC) · Supplement 28AP
1999-07-01Manufacturing (CMC) · Supplement 26AP
1998-10-06Manufacturing (CMC) · Supplement 25AP
1997-10-10Labeling · Supplement 23AP
1997-10-10Manufacturing (CMC) · Supplement 24AP
1997-10-10Manufacturing (CMC) · Supplement 22AP
1997-05-19Manufacturing (CMC) · Supplement 21AP
1996-04-26Manufacturing (CMC) · Supplement 17AP
1996-04-26Manufacturing (CMC) · Supplement 15AP
1996-04-26Manufacturing (CMC) · Supplement 16AP
1994-07-25Manufacturing (CMC) · Supplement 13AP
1994-06-02Manufacturing (CMC) · Supplement 10AP
1994-06-02Labeling · Supplement 11AP
1994-06-02Manufacturing (CMC) · Supplement 12AP
1994-03-04Labeling · Supplement 14AP
1993-08-13Manufacturing (CMC) · Supplement 7AP
1993-08-13Manufacturing (CMC) · Supplement 5AP
1993-07-14Manufacturing (CMC) · Supplement 8AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →