APPLICATION
ANDA077732
TYPE
ANDA
ORIGINAL APPROVAL
2010-04-06
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 12.5MG, LOSARTAN POTASSIUM 50MG · TABLET · ORAL
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG, LOSARTAN POTASSIUM 100MG · TABLET · ORAL
Approval history
2025-10-09Labeling · Supplement 13 · standardAP
2023-11-18Labeling · Supplement 12 · standardAP
2022-07-13Labeling · Supplement 11 · standardAP
2020-01-28Labeling · Supplement 9 · standardAP
2020-01-28Labeling · Supplement 10 · standardAP
2017-02-21Labeling · Supplement 8 · standardAP
2015-06-13Labeling · Supplement 7 · standardAP
2015-06-13Labeling · Supplement 6 · standardAP
2013-01-28Labeling · Supplement 5 · standardAP
2011-09-30Labeling · Supplement 1AP
2010-10-06OriginalAP
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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