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`U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
`FOOD AND DRUG ADMINISTRATION
`CENTER FOR DRUG EVALUATION AND RESEARCH
`OFFICE OF PHARMACEUTICAL SCIENCE
`OFFICE OF GENERIC DRUGS
`
`
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`WITH
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`THERAPEUTIC
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`EQUIVALENCE
`EVALUATIONS
`
`27th EDITION
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`THE PRODUCTS IN THIS LIST HAVE BEEN APPROVED UNDER
`
`SECTION 505 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.
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`2007
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`FOOD AND DRUG ADMINISTRATION
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`CENTER FOR DRUG EVALUATION AND RESEARCH
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`APPROVED DRUG PRODUCTS
`
`with
`
`Therapeutic Equivalence Evaluations
`
`
`
`CONTENTS
`
`PAGE
`
`Therapeutic Equivalence-Related Terms .......................................................................... v
`1.2
`Statistical Criteria for Bioequivalence .............................................................................. vii
`1.3
`Reference Listed Drug ...................................................................................................... ix
`1.4
`General Policies and Legal Status ................................................................................... ix
`1.5
`Practitioner/User Responsibilities ...................................................................................... x
`1.6
`Therapeutic Equivalence Evaluations Codes .................................................................. xii
`1.7
`Description of Special Situations .................................................................................... xix
`1.8
`Therapeutic Equivalence Code Change for a Drug Entity .............................................. xxi
`1.9
`1.10 Change of the Therapeutic Equivalence Evaluation for a Single Product ...................... xxi
`1.11
`Discontinued Section ..................................................................................................... xxii
`
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`ÕÕÕÈ
`
`PREFACE TO TWENTY SEVENTH EDITION ........................................................ iv
`
`1
`1.1
`
`INTRODUCTION .................................................................................................................... v
`Content and Exclusion ....................................................................................................... v
`
`1.12 Changes to the Orange Book ........................................................................................ xxii
`1.13 Availability of the Edition ................................................................................................ xxii
`
`2
`
`HOW TO USE THE DRUG PRODUCTS LISTS .............................................................. 2-1
`
`2.1
`2.2
`2.3
`
`Key Sections for Using the Drug Product Lists ..................................................... 2-1
`Drug Product Illustration ................................................................................. 2-3
`Therapeutic Equivalence Evaluations Illustration ................................................. 2-4
`
`DRUG PRODUCT LISTS
`
`Prescription Drug Product List ................................................................................... 3-1
`OTC Drug Product List ............................................................................................ 4-1
`Drug Products with Approval under Section 505 of the Act Administered
`by the Center for Biologics Evaluation and Research List ......................................... 5-1
`Discontinued Drug Product List .................................................................................. 6-1
`Orphan Products Designations and Approvals List
`........................................................ 7-1
`Drug Products Which Must Demonstrate in vivo Bioavailability
`Only if Product Fails to Achieve Adequate Dissolution .................................................... 8-1
`
`APPENDICES
`A. Product Name Index .................................................................................. A-1
`
`B. Product Name Index Listed by Applicant ........................................................ B-1
`C. Uniform Terms .......................................................................................... C-1
`
`PATENT AND EXCLUSIVITY INFORMATION ADDENDUM ..............................................AD1
`
`A. Patent and Exclusivity Lists ......................................................................ADA1
`B. Patent and Exclusivity Terms .................................................................... ADB1
`
`

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`
`

`

`the final version of the List incorporated appropriate corrections and
`additions.
`Each subsequent edition has included the new approvals and made
`appropriate changes in data.
`
`the President signed into law the Drug Price
`On September 24, 1984,
`Competition and Patent Term Restoration Act
`(1984 Amendments).
`The 1984
`Amendments require that FDA, among other things, make publicly available a
`list of approved drug products with monthly supplements.
`The Approved Drug
`Products with Therapeutic Equivalence Evaluations publication and its monthly
`Cumulative Supplements satisfy this requirement.
`The Addendum to this
`publication identifies drugs that qualify under the 1984 Amendments for
`periods of exclusivity (during which ANDAs or applications described in
`Section 505(b)(2) of the Act for those drugs may not be submitted for a
`specified period of time and, if allowed to be submitted, would be tentatively
`approved) and provides patent information concerning the listed drugs which
`also may delay the approval of ANDAs or Section 505(b)(2) applications.
`The
`Addendum also provides additional information that may be helpful to those
`submitting a new drug application to the Agency.
`
`7
`82,7+,

22 6 22 

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`
`The Agency intends to use this publication to further its objective of
`obtaining input and comment on the publication itself and related Agency
`procedures. Therefore, if you have comments on how the publication can be
`improved, please send them to the Director, Division of Labeling and Program
`Support, HFD—610, Office of Generic Drugs, Center for Drug and Evaluation and
`Research, 7500 Standish Place, Rockville, MD
`20855.
`Comments received are
`publicly available to the extent allowable under the Freedom of Information
`regulations.
`
`ÕÖÈ
`
`iv
`
`

`

`1. INTRODUCTION
`
`1.1 Content and Exclusion
`
`(1) approved prescription drug
`The List is composed of four parts:
`products with therapeutic equivalence evaluations;
`(2) approved
`over—the—counter
`(OTC) drug products for those drugs that may not be marketed
`without NDAs or ANDAs because they are not covered under existing OTC
`monographs;
`(3) drug products with approval under Section 505 of the Act
`administered by the Center for Biologics Evaluation and Research; and (4) a
`cumulative list of approved products that have never been marketed, are for
`exportation, are for military use, have been discontinued from marketing, or
`have had their approvals withdrawn for other than safety or efficacy reasons
`subsequent to being discontinued from marketing.1 This publication also
`includes indices of prescription and OTC drug products by trade or established
`name (if no trade name exists) and by applicant name
`(holder of the approved
`application). All established names for active ingredients generally conform
`to official compendial names or United States Adopted Names
`(USAN) as
`prescribed in (21 CFR 299.4(e)).
`The latter list includes applicants’ names
`as abbreviated in this publication;
`in addition, a list of uniform terms is
`provided.
`An Addendum contains drug patent and exclusivity information for
`the Prescription and OTC Drug Product Lists, and for the Drug Products with
`Approval under Section 505 of the Act Administered by the Center for Biologics
`Evaluation and Research.
`The publication may include additional information
`that the Agency deems appropriate to disseminate.
`
`st¤Ÿ¦ ›œ¡§¦¤›Ÿ
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`ÖÈ
`
`the publication had excluded OTC drug products
`Prior to the 6th Edition,
`and drug products with approval under Section 505 of the Act administered by
`the Center for Biologics Evaluation and Research because the main purpose of
`the publication was to provide information to states regarding FDA's
`recommendation as to which generic prescription drug products were acceptable
`candidates for drug product selection.
`The 1984 Amendments required the
`Agency to begin publishing an up—to—date list of all marketed drug products,
`OTC as well as prescription,
`that have been approved for safety and efficacy
`and for which new drug applications are required.
`
`some drug products were given tentative
`Under the 1984 Amendments,
`approvals. Prior to the effective date,
`the Agency will not include drug
`products with tentative approval in the List; however,
`they are available at
`http://www.fda.gov/cder/ogd/approvals/default.htm. When the tentative
`approval becomes a full approval through a subsequent action letter to the
`application holder,
`the Agency will list the drug product and the final,
`effective approval date in the appropriate approved drug product list.
`
`Distributors or repackagers of products on the List are not identified.
`Because distributors or repackagers are not required to notify FDA when they
`shift their sources of supply from one approved manufacturer to another, it is
`not possible to maintain complete information linking product approval with
`the distributor or repackager handling the products.
`
`1.2 Therapeutic Equivalence-Related Terms
`
`Pharmaceutical Equivalents. Drug products are considered pharmaceutical
`equivalents if they contain the same active ingredient(s), are of the same
`dosage form, route of administration and are identical in strength or
`concentration (e.g., chlordiazepoxide hydrochloride, 5mg capsules).
`Pharmaceutically equivalent drug products are formulated to contain the same
`amount of active ingredient in the same dosage form and to meet the same or
`
`1 Newly approved products are added to parts 1, 2, or 3, of the List, depending on the dispensing
`requirements (prescription or OTC) or approval authority, unless the Orange Book staff is
`otherwise notified before publication.
`
`

`

`

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