Drugs Data File Document Addresses

$179 / year

This dataset contains the Application Documents part to build the Drugs@FDA database. Application Documents refers to “document addresses or URLs to letters, labels, reviews, Consumer Information Sheets, FDA Talk Papers, and other types. Drugs at FDA provides information of drug name, active ingredient, strength, application number, label info, dosage form or route, marketing status as well as patient information, approval letters, review and other facts for drugs approved after 1997.

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

Date Created

2016

Last Modified

2019-01-29

Version

2019-01-29

Update Frequency

Weekly

Temporal Coverage

N/A

Spatial Coverage

N/A

Source

John Snow Labs; US Food and Drug Administration;

Source License URL

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_Document_Type_IdUnique ID assigned to the type of application documentintegerlevel : Nominal
Application_NumberApplication number of the FDA approved drugintegerlevel : Nominal
Submission_TypeApplication submission type.string-
Submission_NumberDocument submission numberstring-
Application_Document_TitleTitle of the application documentstring-
Application_Document_URLApplication document URLstring-
Application_Document_DateDate of document submissiondatetime-
Application_Document_IdApplication_Document_Type_IdApplication_NumberSubmission_TypeSubmission_NumberApplication_Document_TitleApplication_Document_URLApplication_Document_Date
235471019084ORIG10http://www.fda.gov/drugs/drugsafety/ucm362415.htm2014-02-07T00:00:00
235621019927ORIG10http://www.fda.gov/drugs/drugsafety/ucm362415.htm2014-02-07T00:00:00
235741020310ORIG10http://www.fda.gov/drugs/drugsafety/ucm362415.htm2014-02-07T00:00:00
236991022161ORIG10http://www.fda.gov/drugs/drugsafety/ucm375654.htm2014-02-07T00:00:00
440231018533ORIG10http://www.fda.gov/drugs/drugsafety/ucm362415.htm2014-02-07T00:00:00
441551021845ORIG10http://www.fda.gov/Drugs/DrugSafety/ucm390876.htm2014-06-20T00:00:00
441651021985ORIG10http://www.fda.gov/Drugs/DrugSafety/ucm300889.htm2012-11-23T00:00:00
441811022307ORIG10http://www.fda.gov/Drugs/DrugSafety/ucm423079.htm2014-12-23T00:00:00
2395310125427ORIG10http://www.fda.gov/drugs/drugsafety/ucm350733.htm2014-02-07T00:00:00
237971076072ORIG10http://www.fda.gov/cder/drug/antidepressants/default.htm2007-05-09T00:00:00