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(iii) To determine whether the manufacturer of the drug identified as set forth 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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Next, you need to introduce the product subcutaneously into fat tissue

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However, patients with dihydrobiopterin deficiency may develop early brain atrophy and intracranial perivascular calcifications [118, 119]