← FDA DRUG APPROVALS
FDA ANDA · ANDA090317
METOPROLOL
metoprolol tartrate injection
Sponsor: ONESOURCE SPECIALTY
APPLICATION
ANDA090317
TYPE
ANDA
ORIGINAL APPROVAL
2010-04-19
LATEST ACTION
2026-03-18
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
METOPROLOL TARTRATEDiscontinued
METOPROLOL TARTRATE 1MG/ML · INJECTABLE · INJECTION
Approval history
2026-03-18Labeling · Supplement 12 · standardAP
2026-03-18Labeling · Supplement 10 · standardAP
2026-03-18Labeling · Supplement 13 · standardAP
2016-01-21Labeling · Supplement 4 · standardAP
2016-01-21Labeling · Supplement 5 · standardAP
2010-04-19OriginalAP
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.