APPLICATION
ANDA074644
TYPE
ANDA
ORIGINAL APPROVAL
1996-12-10
LATEST ACTION
2024-08-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METOPROLOL TARTRATEPrescription
METOPROLOL TARTRATE 50MG · TABLET · ORAL
METOPROLOL TARTRATEPrescription
METOPROLOL TARTRATE 100MG · TABLET · ORAL
Approval history
2024-08-23Labeling · Supplement 55 · standardAP
2015-10-26Labeling · Supplement 40 · standardAP
2015-10-26Labeling · Supplement 37 · standardAP
2013-02-19Labeling · Supplement 31AP
2011-03-03Labeling · Supplement 19AP
2010-02-26Labeling · Supplement 29AP
2009-06-15Labeling · Supplement 24AP
2008-12-15Labeling · Supplement 28AP
2008-09-16Labeling · Supplement 22AP
2008-03-05Labeling · Supplement 25AP
2006-11-17Labeling · Supplement 20AP
2003-03-10Labeling · Supplement 10AP
2002-10-11Manufacturing (CMC) · Supplement 4AP
2000-10-05Labeling · Supplement 1AP
1996-12-10OriginalAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.