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HE Jo.\"/7: 1?8/S.llffbor,7Ko:3CUMULATIVE SUPPLEMENT 6 JAN\'98...JUN\'98WITH THERAPEUTIC EQUIVALENCE EVALUATIONS 18TH EDITIONU.S. DEPARTMi;NT OF HE.AlTH AND HUMAN SERVICES PUIUC HU.I.TH nRVa fflOO
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What is orange book preface?
The Orange Book Preface is an introduction to the FDA's publication that lists approved drug products with therapeutic equivalence evaluations, intended to provide guidance on the use and interpretation of the information contained within the Orange Book.
Who is required to file orange book preface?
Manufacturers of approved drug products are required to file the Orange Book Preface as part of their compliance with FDA regulations.
How to fill out orange book preface?
To fill out the Orange Book Preface, users must follow the FDA's guidelines, providing relevant product information such as drug name, applicant details, and specific data that pertains to the drug's approval status.
What is the purpose of orange book preface?
The purpose of the Orange Book Preface is to provide context, definitions, and guidelines on how to interpret the drug approval listings and therapeutic equivalence information published in the Orange Book.
What information must be reported on orange book preface?
The Orange Book Preface must include information such as product names, application numbers, active ingredients, and details about the therapeutic equivalence of the products.
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