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Approved Drug Products With Therapeutic Equivalance Evaluations (FDA Orange Book)
Publisher: U. S. Government Publications
Approved Drug Products With Therapeutic Equivalance Evaluations (FDA Orange Book)Pharmacy & Pharmaceutical Research

See the companion Red Book, which covers pricing.

The publication, Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book), identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act). Drugs on the market approved only on the basis of safety (covered by the ongoing Drug Efficacy Study Implementation [DESI] review [e.g., Donnatal® Tablets and Librax® Capsules] or pre-1938 drugs [e.g., Phenobarbital Tablets]) are not included in this publication. The main criterion for the inclusion of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons. Inclusion of products on the List is independent of any current regulatory action through administrative or judicial means against a drug product. In addition, the List contains therapeutic equivalence evaluations for approved multisource prescription drug products. These evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the area of drug product selection and to foster containment of health care costs. Therapeutic equivalence evaluations in this publication are not official FDA actions affecting the legal status of products under the Act.

Background of the Publication.
To contain drug costs, virtually every state has adopted laws and/or regulations that encourage the substitution of drug products. These state laws generally require either that substitution be limited to drugs on a specific list (the positive formulary approach) or that it be permitted for all drugs except those prohibited by a particular list (the negative formulary approach). Because of the number of requests in the late 1970s for FDA assistance in preparing both positive and negative formularies, it became apparent that FDA could not serve the needs of each state on an individual basis. The Agency also recognized that providing a single list based on common criteria would be preferable to evaluating drug products on the basis of differing definitions and criteria in various state laws. As a result, on May 31, 1978, the Commissioner of the Food and Drug Administration sent a letter to officials of each state stating FDA's intent to provide a list of all prescription drug products that are approved by FDA for safety and effectiveness, along with therapeutic equivalence determinations for multisource prescription products.

The List was distributed as a proposal in January l979. It included only currently marketed prescription drug products approved by FDA through new drug applications (NDAs) and abbreviated new drug applications (ANDAs) under the provisions of Section 505 of the Act.

The therapeutic equivalence evaluations in the List reflect FDA's application of specific criteria to the multisource prescription drug products on the List approved under Section 505 of the Act. These evaluations are presented in the form of code letters that indicate the basis for the evaluation made. An explanation of the code appears in the Introduction.

On September 24, 1984, the President signed into law the Drug Price 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.

Content and Exclusion
The List is composed of four parts: (1) approved prescription drug 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. [Note: 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.]

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, OTC, Discontinued 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.

VideoDisc Approved Drug Products With Therapeutic Equivalance Evaluations (Orange Book ASCII Date File), 37th Edition, 2017, International

   
Approved Drug Products With Therapeutic Equivalance Evaluations (Orange Book ASCII Date File), 37th Edition, 2017, International
Format ASCII Data File
Medium DVD
Publisher Catalog Number 917-044-00000-7-DAT-INT
Copyright Year 2016
Caveat Call For Pricing. This product is non-returnable. No refunds.

The Orange Book data files are current. Approximately 5MB of data.

1.       PRODUCTS.TXT

Tilde (~) delimited Orange Book approved products:

Ingredient

The active ingredient(s) for the product. Multiple ingredients are in alphabetical order separated by a semicolon.

Dosage form;Route of Administration

The product dosage form and route separated by a semi-colon.  The format is not all uppercase.

Trade Name

The trade name of the product as shown on the labeling.

Applicant

The firm name holding legal responsibility for the new drug application.  The firm name is condensed to a maximum twenty character unique string.

Strength

The potency of the active ingredient.  May repeat for multiple part products.

New Drug Application Type

The type of new drug application approval.  New Drug Applications (NDA or innovator)  are ”N”.   Abbreviated New Drug Applications (ANDA or generic) are “A”.

New Drug Application (NDA) Number

The FDA assigned number to the application. Format is nnnnnn. 

Product Number

The FDA assigned number to identify the application products. Each strength is a separate product.  May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code

The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date

The date the product was approved as stated in the FDA approval letter to the applicant.  The format is Mmm dd, yyyy.  Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982".

Reference Listed Drug (RLD)

The pioneer or innovator of the drug.  The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference.  Format is Yes or No.

Type

The group or category of approved drugs.  Format is RX, OTC, DISCN.

Applicant Full Name

The full name of the firm holding legal responsibility for the new drug application.


 2.       PATENT.TXT

tilde (~) delimited Orange Book Patent/Exclusivity data files:

New Drug Application Type

The type of new drug application approval.  New Drug Applications (NDA or innovator)  are ”N”.   Abbreviated New Drug Applications (ANDA or generic) are “A”.

New Drug Application (NDA) Number

The FDA assigned number to the application. Format is nnnnnn.

Product Number

The FDA assigned number to identify the application products.  Each strength is a separate product.  May repeat for multiple part products. Format is nnn.

Patent Number

Patent numbers as submitted by the applicant holder for patents covered by the statutory provisions.  May repeat for multiple applications and multiple products. Includes pediatric exclusivity granted by the agency.  Format is nnnnnnnnnnn.

Patent Expire Date

The date the patent expires as submitted by the applicant holder including applicable extensions.  The format is MMM DD, YYYY.

Drug Substance Flag

Patents submitted on FDA Form 3542 and listed after August 18, 2003 may have a drug substance flag indicating the sponsor submitted the patent as claiming the drug substance.   Format is Y or null. 

Drug Product Flag

Patents submitted on FDA Form 3542 and listed after August 18, 2003 may have a drug product flag indicating the sponsor submitted the patent as claiming the drug product.   Format is Y or null.  

Patent Use Code

Code to designate a use patent that covers the approved indication or use of a drug product.  May repeat for multiple applications, multiple products and multiple patents.  Format is nnnnnnnnnn.  

Patent Delist Request Flag

Sponsor has requested patent be delisted.  This patent has remained listed because, under Section 505(j)(5)(D)(i) of the Act, a first applicant may retain eligibility for 180-day exclusivity based on a paragraph IV certification to this patent for a certain period.  Applicants under Section 505(b)(2) are not required to certify to patents where this flag is set to Y.  Format is Y or null.


3.      EXCLUSIVITY.TXT

Tilde (~) delimited Orange Book Patent/Exclusivity data files:

New Drug Application Type

The type of new drug application approval. New Drug Applications (NDA or innovator) are ”N”. Abbreviated New Drug Applications (ANDA or generic) are “A”.

New Drug Application (NDA) Number

The FDA assigned number to the application.  Format is nnnnnn.

Product Number

The FDA assigned number to identify the application products. Each strength is a separate product.  May repeat for multiple part products.  Format is nnn.

Exclusivity Code

Code to designate exclusivity granted by the FDA to a drug product.  Format is nnnnnnnnnn.

Exclusivity Date

The date the exclusivity expires. Format is MMM DD, YYYY.

Electronic Orange Book Appendices

1.     APPENDIX A

Product Name Index (Prescription and OTC Drug Product Lists). An index of drug products by established or trade name updated quarterly. 

2.     APPENDIX B 

Product Name Index Listed by Applicant (Prescription and OTC Product Lists). An index that cross-references applicants to drug products updated quarterly.

3.    APPENDIX C 

Uniform terms. Used to designate dosage forms, routes of administration, and abbreviations used to designate strengths.



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