APPLICATION
ANDA078085
TYPE
ANDA
ORIGINAL APPROVAL
2008-04-29
LATEST ACTION
2025-06-11
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
METOPROLOL TARTRATEPrescription
METOPROLOL TARTRATE 1MG/ML · INJECTABLE · INJECTION
Approval history
2025-06-11Labeling · Supplement 19 · standardAP
2021-10-25Labeling · Supplement 13 · standardAP
2019-10-30Labeling · Supplement 9 · standardAP
2015-08-13Labeling · Supplement 7 · standardAP
2013-02-27Labeling · Supplement 6 · standardAP
2010-03-10Labeling · Supplement 4AP
2008-11-04Labeling · Supplement 2AP
2008-04-29OriginalAP
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.
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