Drugs Application Number and Sponsor

$79 / year

This dataset contains the Applications 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

Source: 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 Applications

Name Description Type Constraints
Application_NumberApplication number of FDA approved drug productintegerlevel : Nominal
Application_TypeTyep of application. Values: A=ANDA, N=NDA, B=BLAstringenum : Array
Sponsor_ApplicantApplicant sponsor.string-
Is_Most_Recent_Label_Available_FlagMost recent label available flag available or notboolean-
Is_Current_Patent_FlagIs the current patent flag availableboolean-
Action_TypeType of action taken by FDAstring-
Chemical_TypeTyep of chemicalintegerlevel : Nominal
Therapeutic_PotentialTherapeutic Potential of the drugstring-
Orphan_CodeDrug orphan codestring-
Application_NumberApplication_TypeSponsor_ApplicantIs_Most_Recent_Label_Available_FlagIs_Current_Patent_FlagAction_TypeChemical_TypeTherapeutic_PotentialOrphan_Code
74047ABARRfalsefalseTA
76168ATEVAfalsefalseTA
76597ABARRfalsefalseTA
76610ATEVAfalsefalseTA
90476ABARRfalsefalseTA
40047ANOVENfalsefalseTA
40048ANOVENfalsefalseTA
40049ANOVENfalsefalseTA
70336AMYLANfalsefalseAP
70337AMYLANfalsefalseAP