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Unichem Laboratories has received ANDA
approval from USFDA for Unichem's Chlorthalidone Tablets USP, 25 mg and 50
mg to market a generic version of Hygroton® Tablets, 25 mg and 50 mg of Sanofi
Aventis US, LLC which are indicated for:
■ the management of hypertension either as the sole therapeutic agent or to
enhance the effect of other antihypertensive drugs in the more severe forms
of hypertension.
■ adjunctive therapy in edema associated with congestive heart failure, hepatic
cirrhosis, and corticosteroid and estrogen therapy.
■ the treatment of edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.
The Product will be commercialized from Unichem's Ghaziabad plant.
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