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FDA ANDA · ANDA203145
VALSARTAN AND HYDROCHLOROTHIAZIDE
Sponsor: MACLEODS PHARMS LTD
APPLICATION
ANDA203145
TYPE
ANDA
ORIGINAL APPROVAL
2013-04-19
LATEST ACTION
2023-06-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
VALSARTAN AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, VALSARTAN 320MG · TABLET · ORAL
VALSARTAN AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, VALSARTAN 80MG · TABLET · ORAL
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
Approval history
2023-06-07Labeling · Supplement 37 · standardAP
2022-02-14Labeling · Supplement 26 · standardAP
2019-08-20Labeling · Supplement 24 · standardAP
2016-08-29Manufacturing (CMC) · Supplement 13 · unknownAP
2015-10-27Labeling · Supplement 2 · standardAP
2015-10-27Labeling · Supplement 9 · standardAP
2015-10-27Labeling · Supplement 5 · standardAP
2013-04-19UNKNOWN · 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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