← FDA DRUG APPROVALS

FDA ANDA · ANDA078459

METOPROLOL TARTRATE

Sponsor: IPCA LABS LTD

APPLICATION
ANDA078459
TYPE
ANDA
ORIGINAL APPROVAL
2008-06-17
LATEST ACTION
2024-03-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2024-03-12Labeling · Supplement 16 · standardAP
2024-03-12Labeling · Supplement 15 · standardAP
2015-08-20Labeling · Supplement 10 · standardAP
2011-07-12Labeling · Supplement 7AP
2011-06-30Labeling · Supplement 6AP
2008-06-17OriginalAP
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 →