APPLICATION
ANDA074453
TYPE
ANDA
ORIGINAL APPROVAL
1995-04-27
LATEST ACTION
2025-09-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METOPROLOL TARTRATEPrescription
METOPROLOL TARTRATE 50MG · TABLET · ORAL
METOPROLOL TARTRATEPrescription
METOPROLOL TARTRATE 100MG · TABLET · ORAL
Approval history
2025-09-03Labeling · Supplement 2 · standardAP
2025-09-03Labeling · Supplement 6 · standardAP
2025-09-03Labeling · Supplement 4 · standardAP
1995-04-27OriginalAP
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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