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(iii) To determine whether the manufacturer of the drug identified in this paragraph (a)(3) is a first applicant during the 180-day exclusivity period, or whether the manufacturer of this drug is a first approved applicant for a competitive generic drug therapy, CMS will refer to publicly available FDA sources such as the Orange Book and may consult with FDA for technical assistance as needed

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Sankhla B, Kachhwaha K, Hussain SY, Saxena S, Sireesha SK, Bhargava A

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