← FDA DRUG APPROVALS

FDA ANDA · ANDA073288

METOPROLOL TARTRATE

Sponsor: CHARTWELL RX

APPLICATION
ANDA073288
TYPE
ANDA
ORIGINAL APPROVAL
1994-03-25
LATEST ACTION
2013-02-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

METOPROLOL TARTRATEDiscontinued
METOPROLOL TARTRATE 50MG · TABLET · ORAL

Approval history

2013-02-19Labeling · Supplement 35AP
2010-04-09Labeling · Supplement 34AP
2009-03-16Labeling · Supplement 30AP
2008-06-11Labeling · Supplement 27AP
2008-02-14Labeling · Supplement 26AP
2007-06-21Labeling · Supplement 24AP
2002-08-05Manufacturing (CMC) · Supplement 19AP
2001-08-21Manufacturing (CMC) · Supplement 17AP
2001-06-08Labeling · Supplement 11AP
2001-06-08Manufacturing (CMC) · Supplement 9AP
2001-06-08Manufacturing (CMC) · Supplement 10AP
2001-06-07Manufacturing (CMC) · Supplement 16AP
2001-04-02Manufacturing (CMC) · Supplement 15AP
2001-04-02Manufacturing (CMC) · Supplement 13AP
2001-04-02Labeling · Supplement 14AP
2000-08-07Labeling · Supplement 12AP
1999-11-17Manufacturing (CMC) · Supplement 7AP
1999-03-03Manufacturing (CMC) · Supplement 4AP
1999-03-03Labeling · Supplement 5AP
1999-01-29Manufacturing (CMC) · Supplement 3AP
1997-03-03Labeling · Supplement 2AP
1996-11-13Manufacturing (CMC) · Supplement 1AP
1994-03-25OriginalAP
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 →