APPLICATION
ANDA078020
TYPE
ANDA
ORIGINAL APPROVAL
2012-09-21
LATEST ACTION
2024-04-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
VALSARTAN AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 25MG, VALSARTAN 320MG · TABLET · ORAL
VALSARTAN AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 25MG, VALSARTAN 160MG · TABLET · ORAL
VALSARTAN AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, VALSARTAN 80MG · TABLET · ORAL
VALSARTAN AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, VALSARTAN 320MG · TABLET · ORAL
VALSARTAN AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, VALSARTAN 160MG · TABLET · ORAL
Approval history
2024-04-11Labeling · Supplement 15 · standardAP
2019-09-06Labeling · Supplement 13 · standardAP
2015-12-01Labeling · Supplement 8 · standardAP
2015-07-15Labeling · Supplement 7 · standardAP
2015-07-15Labeling · Supplement 5 · standardAP
2012-12-14Labeling · Supplement 2 · 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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