Determination of Regulatory Review Period for Purposes of Patent Extension; AldaraSUPTM/SUP (5,238,944)

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The Food and Drug Administration (FDA) has determined the regulatory review period for Aldara TM (5,238,944) and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Commissioner of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.