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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
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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