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Ph.D. Orange Book Contents Page General Information 1 School of Education Committees 2 Office of Academic Services 3 Doctoral Requirements (descriptions) EDU 781 exemption guidelines, limits on transfer
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What is orange book contents page?
The orange book contents page contains a list of all drug products approved by the FDA and their therapeutic equivalence evaluations.
Who is required to file orange book contents page?
Drug manufacturers or sponsors are required to file the orange book contents page.
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The orange book contents page can be filled out online on the FDA's website using the Electronic Submissions Gateway.
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The purpose of the orange book contents page is to provide healthcare professionals and the public with information about approved drug products and their equivalence evaluations.
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Information such as the drug product's name, active ingredients, strength, dosage form, and approved marketing status must be reported on the orange book contents page.
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