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Electronic Orange Book (EOB) Query data files

Posted Sep 20 2010 12:20pm

The following describes the Approved Drug Products EOB Query web files.  The files are ASCII text tilde (~) delimited.  They are zipped into a file:

  • EOBZIP.ZIP   (Last updated 9/20/2010) Allow for approximately 5 megabytes for the unzip process.

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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