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tobacco brands at the time [40]overcame the obscurity and perception of the unfortunately-named Good Luck Sak-Pak as potentially a sissy product, a perception that would follow pouched MST for decades through its many iterations [35, 36]

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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