Drugs Database Products Included

$79 / year

This dataset contains the Product 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”

Product table ” contains the products included in each application. Includes form, dosage, and route.” (1)

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 at FDA Database Products, Drugs@FDA Database Products

Name Description Type Constraints
Application_NumberApplication number of FDA approved drug productstring-
Product_NumberProduct number of FDA approved drug productstring-
Dosage_Form_and_Route_of_AdministrationRoute of administration and dosage form of the drugstring-
StrengthRecommended drug dosestring-
Reference_Listed_DrugA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. Values: 0= Not reference listed drug, 1= Reference listed drug, 2= To be Determinedintegerlevel : Nominal
Brand_NameBrand name of the drugstring-
Active_IngredientActive ingredient present in the drugstring-
Application_NumberProduct_NumberDosage_Form_and_Route_of_AdministrationStrengthReference_Listed_DrugBrand_NameActive_Ingredient
017473001TABLET;ORAL2MG1ORAPPIMOZIDE
017473003TABLET;ORAL1MG1ORAPPIMOZIDE
021794001GEL;TOPICAL5%1ACZONEDAPSONE
202067001TABLET;ORAL5MG0ONFICLOBAZAM
006309001CREAM;TOPICAL1%0KWELLLINDANE
020855001TABLET;ORAL400MG1MESNEXMESNA
070423001TABLET;ORAL2MG0Q-PAMDIAZEPAM
070424001TABLET;ORAL5MG0Q-PAMDIAZEPAM
072431001TABLET;ORAL2MG0Q-PAMDIAZEPAM
072432001TABLET;ORAL5MG0Q-PAMDIAZEPAM