|
Orange Book Information Data Files
The Orange Book data files are current through November 2008. Every
effort has been made to prevent errors and discrepancies in the
Approved Drug Products data files. However, if you detect an
error or discrepancy in drug data, please send a brief description
of the data problem to the following e-mail address: DRUGPRODUCTS@CDER.FDA.GOV.
General questions related to the drug data in these files should
be directed to the Center for Drug Evaluation and Research, Drug
Information Branch at the following e-mail account: DRUGINFO@FDA.HHS.GOV.
Requests for more specific information should be submitted in
writing or directed to the FDA's Freedom of Information Staff
at:
Food and Drug Administration
Freedom of Information Office,
HFI-35
5600 Fishers Lane
Rockville, MD 20857
Telephone:
(301) 827-6500
The CDER Freedom
of Information Office Electronic Reading Room. provides
background information about the FOI process.
The following describes the Approved Drug Products EOB Query web
files. The files are ASCII text tilde (~) delimited.
They are zipped into a self-extracting file, EOBZIP.ZIP or EOBZIP.EXE.
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
Trade Name
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
New Drug Application (NDA) Number
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
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
2. PATENT.TXT
tilde (~) delimited Orange Book Patent/Exclusivity data
files:
New Drug Application (NDA) Number
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
Electronic Orange Book Appendices
1. APPENDIX
A
2. APPENDIX B
3. APPENDIX C
Uniform terms. Used to designate dosage forms, routes
of administration, and abbreviations used to designate
strengths.
Back
to Top
Back to Orange Book
Date Updated: December 22, 2008 |
|