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FDA ANDA · ANDA218015
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Sponsor: GRANULES
APPLICATION
ANDA218015
TYPE
ANDA
ORIGINAL APPROVAL
2023-09-29
LATEST ACTION
2025-10-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG, LOSARTAN POTASSIUM 100MG · TABLET · ORAL
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG, LOSARTAN POTASSIUM 100MG · TABLET · ORAL
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG, LOSARTAN POTASSIUM 50MG · TABLET · ORAL
Approval history
2025-10-09Labeling · Supplement 2 · standardAP
2023-09-29UNKNOWN · Original · standardAP
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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