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Toprol Xl: Drugs
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TOPROL-XL, metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended release tablets. TOPROL-XL has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt).
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Sandoz introduced metoprolol succinate 25 mg extended release tablets, a generic equivalent of Toprol XL, in the U.S. late last year. Sandoz announced this past May that the U.S. Food and Drug Administration granted final approval to its abbreviated new drug application for metoprolol succinate 50 mg ER.
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The Sandoz generic drugs unit of Novartis in November launched a 25 milligram version of Toprol XL in the United States. Soon afterward London-based AstraZeneca signed a deal allowing Par Pharmaceutical Cos. Inc. (PRX.N: Quote, Profile, Research) to distribute an authorized generic form of its drug in the same dosage strength.
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