← FDA DRUG APPROVALS

FDA NDA · NDA219373

LOPRESSOR

metoprolol tartrate

Sponsor: RUBICON RESEARCH

APPLICATION
NDA219373
TYPE
NDA
ORIGINAL APPROVAL
2025-04-10
LATEST ACTION
2025-11-12
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

LOPRESSOR · ReferencePrescription
METOPROLOL TARTRATE 10MG/ML · SOLUTION · ORAL

Approval history

2025-11-12Labeling · Supplement 1 · standardAP
2025-04-10Type 3 - New Dosage Form · Original · standardLetterAP
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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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