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FDA ANDA · ANDA090654
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
Sponsor: SUN PHARM INDS
APPLICATION
ANDA090654
TYPE
ANDA
ORIGINAL APPROVAL
2012-01-19
LATEST ACTION
2025-06-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG, METOPROLOL TARTRATE 100MG · TABLET · ORAL
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 50MG, METOPROLOL TARTRATE 100MG · TABLET · ORAL
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG, METOPROLOL TARTRATE 50MG · TABLET · ORAL
Approval history
2025-06-20Labeling · Supplement 9 · standardAP
2023-04-25Labeling · Supplement 7 · standardAP
2023-04-25Labeling · Supplement 5 · standardAP
2012-01-19OriginalAP
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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