Food
and Drug Administration
Center for Drug Evaluation and Research
Approved Drug Products
with
Therapeutic Equivalence Evaluations
CONTENTS
PREFACE TO TWENTY SECOND EDITION
(Cumulative Monthly
Supplement)
1. INTRODUCTION
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 Evaluation for a Single Product
1.11 Availability of
Internal Policy and Procedure Guides
1.12 Discontinued Section
HOW TO USE THE DRUG PRODUCTS LISTS
2.1 Key Sections for Using
the Drug Product Lists
2.2 Drug Product Illustration
2.3 Therapeutic Equivalence Evaluations Illustration
DRUG PRODUCT LISTS
3.1 Prescription Drug Product List
3.2 OTC Drug Product List
3.3 Drug Products with Approval under
Section 505 of the Act Administered by the Center for Biologics Evaluation and Research
List
3.4 Discontinued Drug Product List
3.5 Orphan Product
Designations and Approvals List
3.6 Drug Products Which Must Demonstrate
in vivo Bioavailability Only if Product Fails to Achieve Adequate Dissolution
APPENDICES
A. Product Name Index
B. Product Name Index Listed by Applicant
C. Uniform Terms
PATENT
AND EXCLUSIVITY INFORMATION ADDENDUM
A. Patent and Exclusivity Terms
B. Patent and
Exclusivity Lists 
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FDA/Center for Drug Evaluation and Research
Last Updated: April 8, 2002
Originator: OTCOM/DML
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