APPLICATION
ANDA076704
TYPE
ANDA
ORIGINAL APPROVAL
2004-01-16
LATEST ACTION
2024-06-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METOPROLOL TARTRATEPrescription
METOPROLOL TARTRATE 37.5MG · TABLET · ORAL
METOPROLOL TARTRATEPrescription
METOPROLOL TARTRATE 50MG · TABLET · ORAL
METOPROLOL TARTRATEPrescription
METOPROLOL TARTRATE 75MG · TABLET · ORAL
METOPROLOL TARTRATEPrescription
METOPROLOL TARTRATE 100MG · TABLET · ORAL
METOPROLOL TARTRATEPrescription
METOPROLOL TARTRATE 25MG · TABLET · ORAL
Approval history
2024-06-03Labeling · Supplement 41 · standardAP
2024-06-03Labeling · Supplement 45 · standardAP
2015-03-18Manufacturing (CMC) · Supplement 21AP
2015-02-06Labeling · Supplement 20 · standardAP
2011-09-20Labeling · Supplement 17AP
2010-03-12Labeling · Supplement 14AP
2008-10-21Labeling · Supplement 10AP
2008-05-16Labeling · Supplement 9AP
2004-01-16OriginalAP
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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