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FDA ANDA · ANDA205439

HYDROCHLOROTHIAZIDE; VALSARTAN

Sponsor: HUAREN PHARMACEUTICAL CO LTD

APPLICATION
ANDA205439
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

HYDROCHLOROTHIAZIDE; VALSARTANNone (Tentative Approval)
HYDROCHLOROTHIAZIDE 12.5MG, VALSARTAN 320MG · TABLET · ORAL
HYDROCHLOROTHIAZIDE; VALSARTANNone (Tentative Approval)
HYDROCHLOROTHIAZIDE 12.5MG, VALSARTAN 160MG · TABLET · ORAL
HYDROCHLOROTHIAZIDE; VALSARTANNone (Tentative Approval)
HYDROCHLOROTHIAZIDE 25MG, VALSARTAN 320MG · TABLET · ORAL
HYDROCHLOROTHIAZIDE; VALSARTANNone (Tentative Approval)
HYDROCHLOROTHIAZIDE 25MG, VALSARTAN 160MG · TABLET · ORAL

Approval history

2017-09-06UNKNOWN · Original · standardTA
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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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