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news.Roxane Laboratories has received US Food and Drug Administration (FDA)'s approval for its abbreviated new drug application (ANDA) for Losartan Potassium tablets USP and Losartan Potassium and Hydrochlorothiazide tablets.
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The strengths of Losartan Potassium tablets USP approved by FDA are 25mg, 50mg and 100mg while that of Losartan Potassium and Hydrochlorothiazide tablets are 50mg/12.5mg and 100mg/25mg.
Roxane Laboratories claims that the Losartan Potassium tablets USP are AB rated to Cozaar (losartan potassium) tablets while Losartan Potassium and Hydrochlorothiazide tablets are AB rated to Hyzaar (losartan potassium and hydrochlorothiazide) tablets.