Drugs Database Submissions Included

$179 / year

This dataset contains the Application Submission part to build the Drugs@FDA database from the Food and Drug Administration (FDA) Approved Drug Products available on their official website. It provides information on 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.

Complexity

Drugs at FDA allows to search for official information about FDA (Food and Drug Administration) 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

2020-08-18

Version

2020-08-18

Update Frequency

Weekly

Temporal Coverage

2016-2020

Spatial Coverage

United States

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 at FDA Database Products, Drugs at FDA Document Type Lookup, FDA Document Type Lookup

NameDescriptionTypeConstraints
Application_NumberApplication number of FDA approved drug productstring-
Submission_Class_Code_IDThe Submission Classification Code, previously known as the Chemistry Classification Code, is assigned as a “Type” code, for example, “Type 1,” New molecular entity (NME).integerlevel : Nominal
Submission_TypeApplication submission type either original or supplement. For original NDA (New Drug Application) submissions, classification provides a way of categorizing new drug applications. For Supplements, the Submission Classification describes the kind of change to an FDA approved application.string-
Submission_NumberSubmission number assigned to the applicationintegerlevel : Nominal
Submission_StatusStatus of application submission.string-
Submission_Status_DateDate of application submission.date-
Submissions_Public_NotesAdditional notes for the submitted applicationsstring-
Review_PriorityReview priority for the applicationstring-
Application NumberSubmission Class Code IDSubmission TypeSubmission NumberSubmission StatusSubmission Status DateSubmissions Public NotesReview Priority
419.0ORIG1AP1969-07-16UNKNOWN
43.0SUPPL10AP1980-05-08
43.0SUPPL11AP1987-05-26
159ORIG1AP1939-03-09
1593.0SUPPL3AP1986-12-09
1593.0SUPPL4AP1986-05-28
415ORIG1AP1939-02-27
55219.0ORIG1AP1939-02-09UNKNOWN
55221.0SUPPL7AP1975-07-28
55221.0SUPPL8AP1975-07-28