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As proposed at 428.101(a)(3)(iii), to determine whether the manufacturer of the generic drug is a first applicant during the 180-day exclusivity period, or whether the manufacturer of the generic drug is a first approved applicant for a competitive generic drug therapy, CMS would refer to FDA website resources such as the Orange Book and may consult with FDA for technical assistance as needed

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[PubMed] [Google Scholar] 18.Dharmarajan TS, Kanagala MR, Murakonda P, Lebelt AS, Norkus EP