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Aurobindo Pharma Ltd Receives USFDA Final Approval For gValsartan And Hydrochlorothiazide Tablets
Aurobindo Pharma Ltd announced that the Company has received final approvals from the US Food & Drug Administration (USFDA) to manufacture and market Valsartan and Hydrochlorothiazide Tablets USP, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg and 320mg/25mg (ANDA 202519). The product is ready for launch. Valsartan and Hydrochlorothiazide Tablets USP, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg and 320mg/25mg is generic equivalent to Novartis Pharmaceuticals Corp.’s Diovan HCT Tablets 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg and 320mg/25mg respectively. The product is indicated for the treatment of hypertension, to lower blood pressure and falls under the cardiovascular (CVS) therapeutic category.
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