Drugs Data File Document Addresses

$79 / year

This dataset contains the Application Documents part to build the Drugs@FDA database. Drugs at FDA is a database of FDA Approved Drug Products available in the FDA official website for search by drug name, active ingredient or application number. It provides information of drug (generic) name, active ingredient, form and strength available, FDA application number, label info, dosage form or route, marketing status and pharmaceutical company as well as patient information, approval letters, review and other facts for drugs approved after 1997. The information is classified by health information, regulatory information and advanced search. This dataset contains the necessary technical information (excluding programming scripts) to reproduce the online version of Drugs@FDA.

Complexity

Drugs@FDA allows to search for official information about FDA approved innovator and generic drugs and therapeutic biological products. The main uses of Drugs@FDA are: finding labels for approved drug products, generic drug products for an innovator drug product, therapeutically equivalent drug products for an innovator or generic drug product, consumer information for drugs approved from 1998 on, all drugs with a specific active ingredient, viewing the approval history of a drug.

Drugs@FDA contains prescription and over-the-counter human drugs and therapeutic biologicals currently approved for sale in the United States. Drugs@FDA includes discontinued drugs and “Chemical Type 6″ approvals.

Drugs@FDA contains the following therapeutic biological products:
– monoclonal antibodies
– cytokines, growth factors, enzymes, immunomodulators; and thrombolytics
– proteins intended for therapeutic use that are extracted from animals or microorganisms, including recombinant versions of these products (except clotting factors)
– other non-vaccine therapeutic immunotherapies

Not all therapeutic biological products are in Drugs@FDA.
Drugs@FDA contains most of the drug products approved since 1939. The majority of labels, approval letters, reviews, and other information are available for drug products approved from 1998 to the present.

Drugs@FDA does not include:
– over-the-counter (OTC) products approved for marketing through a process other than submission of a New Drug Application or Biologic License Application
– drugs sold outside the United States that are not approved for marketing in the U.S.
– drugs not approved by the FDA
– drugs under review at FDA for which no action (approved or not approved) has occurred yet
– dietary supplements, which do not require FDA approval to be sold in the United States
– biological products regulated by the Center for Biologics Evaluation and Research
– animal drugs, which are regulated by the Center for Veterinary Medicine”

Data definitions:
– ApplicationDocs
– [ApplicationDocsID] [int] IDENTITY(1,1) NOT NULL
– [ApplicationDocsTypeID] [int] NOT NULL
– [ApplNo] [char](6) NOT NULL
– [SubmissionType] [char](10) NOT NULL
– [SubmissionNo] [int] NOT NULL
– [ApplicationDocsTitle] [varchar](100) NULL
– [ApplicationDocsURL] [varchar](200) NULL
– [ApplicationDocsDate] [datetime] NULL

Application Documents refers to “document addresses or URLs to letters, labels, reviews, Consumer Information Sheets, FDA Talk Papers, and other types.” (1)

References:
US Food and Drug Administration, F.D.A. (2016). FDA.gov. Retrieved 8 May, 2016.

Date Created

2016

Last Modified

2016-07-13

Version

2016-07-02

Update Frequency

Weekly

Temporal Coverage

2016

Spatial Coverage

N/A

Source

John Snow Labs => US Food and Drug Administration

Source License URL

John Snow Labs Standard License

Source License Requirements

N/A

Source Citation

N/A

Keywords

Drugs Database, SQL Database, SQL Drugs Database, Online Drug Database, FDA Approved Drug Products, Drugs FDA, FDA Official Drug Website, FDA Generic Drugs List, FDA Therapeutic Biological Products

Other Titles

Drugs@FDA Drugs List, Drugs at FDA Application Documents

NameDescriptionTypeConstraints
Application_Document_IdUnique ID assigned to the application documentintegerlevel : Nominal
Application_NumberApplication number of the FDA approved drugintegerlevel : Nominal
Sequence_NumberApplication document sequence numberintegerlevel : Nominal
Document_TypeType of application documentstring-
Document_TitleTitle of the application documentstring-
Document_URLApplication document URLstring-
Document_DateDate of document submissiondatetime-
Action_TypeType of action taken by FDAstring-
Duplicate_CounterApplication duplicate counterintegerlevel : Nominal
Application_Document_IdApplication_NumberSequence_NumberDocument_TypeDocument_TitleDocument_URLDocument_DateAction_TypeDuplicate_Counter
453712065962OtherSLChttp://www.fda.gov/cder/2016-03-04T00:00:00AP0
390991039515353Labelhttp://deleted per r. berger2014-04-18T00:00:00AP0
5197810Reviewhttp://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19781.cfm1998-05-14T00:00:00AP0
11198320Reviewhttp://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19832.cfm1999-01-06T00:00:00AP0
39204000Reviewhttp://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20400.cfm1998-01-29T00:00:00AP0
88206120Reviewhttp://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20612.cfm1999-06-17T00:00:00AP0
38744040Reviewhttp://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74404.cfm1998-05-14T00:00:00AP0
45744640Reviewhttp://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74464.cfm1998-05-28T00:00:00AP0
46744710Reviewhttp://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74471.cfm1998-03-19T00:00:00AP0
66641420Reviewhttp://www.accessdata.fda.gov/drugsatfda_docs/anda/98/64142.cfm1998-06-25T00:00:00AP0