APPLICATION
ANDA078946
TYPE
ANDA
ORIGINAL APPROVAL
2013-03-21
LATEST ACTION
2024-05-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
VALSARTAN AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG, VALSARTAN 160MG · TABLET · ORAL
VALSARTAN AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG, VALSARTAN 320MG · TABLET · ORAL
VALSARTAN AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG, VALSARTAN 160MG · TABLET · ORAL
VALSARTAN AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG, VALSARTAN 80MG · TABLET · ORAL
VALSARTAN AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG, VALSARTAN 320MG · TABLET · ORAL
Approval history
2024-05-09Labeling · Supplement 10 · standardAP
2019-09-05Labeling · Supplement 7 · standardAP
2019-09-05Labeling · Supplement 6 · standardAP
2015-05-18Labeling · Supplement 3 · standardAP
2015-05-18Labeling · Supplement 4 · standardAP
2013-03-21OriginalAP
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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