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FDA ANDA · ANDA202519
VALSARTAN AND HYDROCHLOROTHIAZIDE
Sponsor: AUROBINDO PHARMA LTD
APPLICATION
ANDA202519
TYPE
ANDA
ORIGINAL APPROVAL
2013-03-21
LATEST ACTION
2022-04-04
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
2022-04-04Labeling · Supplement 15 · standardAP
2019-08-16Labeling · Supplement 12 · standardAP
2019-08-16Labeling · Supplement 5 · standardAP
2015-01-16Labeling · Supplement 4 · standardAP
2015-01-16Labeling · Supplement 3 · standardAP
2013-03-21UNKNOWN · 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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