Determination of Regulatory Review Period for Purposes of Patent Extension; VOQUEZNA DUAL PAK-New Drug Application 215153

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The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VOQUEZNA DUAL PAK--new drug application (NDA) 215153 and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.