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FDA ANDA · ANDA077761

METOPROLOL TARTRATE

metoroprolol tartrate

Sponsor: HIKMA FARMACEUTICA

APPLICATION
ANDA077761
TYPE
ANDA
ORIGINAL APPROVAL
2007-05-30
LATEST ACTION
2025-03-24
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

METOPROLOL TARTRATEPrescription
METOPROLOL TARTRATE 1MG/ML · INJECTABLE · INJECTION

Approval history

2025-03-24Labeling · Supplement 26 · standardAP
2022-01-07Labeling · Supplement 24 · standardAP
2015-11-12Labeling · Supplement 16 · standardAP
2013-02-27Labeling · Supplement 13AP
2010-02-26Labeling · Supplement 10AP
2010-01-19Labeling · Supplement 9AP
2009-02-26Labeling · Supplement 6AP
2007-05-30OriginalAP
VIEW ON DRUGS@FDA ↗

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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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