← FDA DRUG APPROVALS

FDA ANDA · ANDA090617

METOPROLOL SUCCINATE

Sponsor: DR REDDYS LABS LTD

APPLICATION
ANDA090617
TYPE
ANDA
ORIGINAL APPROVAL
2012-08-01
LATEST ACTION
2023-05-09
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

METOPROLOL SUCCINATEPrescription
METOPROLOL SUCCINATE EQ 50MG TARTRATE · TABLET, EXTENDED RELEASE · ORAL
METOPROLOL SUCCINATEPrescription
METOPROLOL SUCCINATE EQ 25MG TARTRATE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2023-05-09Labeling · Supplement 14 · standardAP
2023-05-09Labeling · Supplement 17 · standardAP
2015-12-16Labeling · Supplement 5 · standardAP
2014-01-27Labeling · Supplement 3 · standardAP
2014-01-27Labeling · Supplement 1 · standardAP
2012-08-01OriginalAP
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 →