Approved Drug Products with Therapeutic Equivalence Evaluations 32nd Edition Contents PREFACE 1.1 Content and Exclusion 1.2 Therapeutic Equivalence-Related Terms 1.3 Statistical Criteria for Bioequivalence 1.4 Reference Listed Drug 1.5 General Policies and Legal Status 1.6 Practitioner/User Responsibilities 1.7 Therapeutic Equivalence Evaluations Codes 1.8 Description of Special Situations 1.9 Therapeutic Equivalence Code Change for a Drug Entity 1.10 Change of the Therapeutic Equivalence for a Single Product 1.11 Discontinued Section 1.12 Changes to the Orange Book 1.13 Availability of the Edition