← FDA DRUG APPROVALS

FDA ANDA · ANDA077739

METOPROLOL TARTRATE

Sponsor: AUROBINDO PHARMA

APPLICATION
ANDA077739
TYPE
ANDA
ORIGINAL APPROVAL
2007-09-11
LATEST ACTION
2023-11-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

METOPROLOL TARTRATEPrescription
METOPROLOL TARTRATE 37.5MG · TABLET · ORAL
METOPROLOL TARTRATEPrescription
METOPROLOL TARTRATE 50MG · TABLET · ORAL
METOPROLOL TARTRATEPrescription
METOPROLOL TARTRATE 75MG · TABLET · ORAL
METOPROLOL TARTRATEPrescription
METOPROLOL TARTRATE 100MG · TABLET · ORAL
METOPROLOL TARTRATEPrescription
METOPROLOL TARTRATE 25MG · TABLET · ORAL

Approval history

2023-11-22Labeling · Supplement 30 · standardAP
2015-09-08Labeling · Supplement 13 · standardAP
2014-07-19Manufacturing (CMC) · Supplement 8AP
2013-03-18Labeling · Supplement 11 · standardAP
2013-03-18Labeling · Supplement 9AP
2010-03-12Labeling · Supplement 7AP
2009-02-26Labeling · Supplement 5AP
2008-09-15Labeling · Supplement 2AP
2008-09-15Labeling · Supplement 3AP
2007-09-11OriginalAP
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 →