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This level of tracking helps optimize protocols with precision difficult to achieve through self-assessment

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While the initial Orange Book contained only approved drugs and equivalents, the current Orange Book contains 11 : Approved drug products and therapeutic equivalents Patent and exclusivity information for approved drug products Approved over the counter drug products Drug products approved by CDER (under section 505) but administered by CBER Cumulative list of approved products Importantly, the Orange Book contains only approved drug products regulated by CDER, so tentative approvals and biologics regulated by CBER are not included 12