APPLICATION
ANDA204687
TYPE
ANDA
ORIGINAL APPROVAL
2026-04-23
LATEST ACTION
2026-04-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
VALSARTAN AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 25MG, VALSARTAN 160MG · TABLET · ORAL
VALSARTAN AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, VALSARTAN 160MG · TABLET · ORAL
VALSARTAN AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 25MG, VALSARTAN 320MG · TABLET · ORAL
VALSARTAN AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, VALSARTAN 320MG · TABLET · ORAL
VALSARTAN AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, VALSARTAN 80MG · TABLET · ORAL
Approval history
2026-04-23UNKNOWN · OriginalAP
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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