Others titles
- Drugs at FDA Database Products
- Drugs@FDA Database Products
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
Drugs Database Products Included
This dataset contains the Product part to build the Drugs@FDA database. Drugs at FDA is a database of FDA Approved Drug Products available on the FDA official website. 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.
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Description
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.”
About this Dataset
Data Info
Date Created | 2016 |
---|---|
Last Modified | 2024-06-11 |
Version | 2024-06-11 |
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 at FDA Database Products, Drugs@FDA Database Products |
Data Fields
Name | Description | Type | Constraints |
---|---|---|---|
Application_Number | Application number of FDA approved drug product | string | - |
Product_Number | Product number of FDA approved drug product | string | - |
Dosage_Form | Dosage form of the drug | string | - |
Route_of_Administration | Route of administration of the drug | string | - |
Strength | Recommended drug dose | string | - |
Reference_Listed_Drug | A 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 Determined | integer | level : Nominal |
Brand_Name | Brand name of the drug | string | - |
Active_Ingredient | Active ingredient present in the drug | string | - |
Is_Reference_Standard | Whether or not its a reference standard. | string | - |
Data Preview
Application Number | Product Number | Dosage Form | Route of Administration | Strength | Reference Listed Drug | Brand Name | Active Ingredient | Is Reference Standard |
4 | 4 | SOLUTION/DROPS | OPHTHALMIC | 1% | 0.0 | PAREDRINE | HYDROXYAMPHETAMINE HYDROBROMIDE | True |
159 | 1 | TABLET | ORAL | 500MG | 0.0 | SULFAPYRIDINE | SULFAPYRIDINE | True |
552 | 1 | INJECTABLE | INJECTION | 20,000 UNITS/ML | 0.0 | LIQUAEMIN SODIUM | HEPARIN SODIUM | True |
552 | 2 | INJECTABLE | INJECTION | 40,000 UNITS/ML | 0.0 | LIQUAEMIN SODIUM | HEPARIN SODIUM | True |
552 | 3 | INJECTABLE | INJECTION | 5,000 UNITS/ML | 0.0 | LIQUAEMIN SODIUM | HEPARIN SODIUM | True |
552 | 4 | INJECTABLE | INJECTION | 1,000 UNITS/ML | 0.0 | LIQUAEMIN SODIUM | HEPARIN SODIUM | True |
552 | 5 | INJECTABLE | INJECTION | 10,000 UNITS/ML | 0.0 | LIQUAEMIN SODIUM | HEPARIN SODIUM | True |
552 | 7 | INJECTABLE | INJECTION | 100 UNITS/ML | 0.0 | LIQUAEMIN LOCK FLUSH | HEPARIN SODIUM | True |
552 | 8 | INJECTABLE | INJECTION | 1,000 UNITS/ML | 0.0 | HEPARIN SODIUM | HEPARIN SODIUM | True |
552 | 9 | INJECTABLE | INJECTION | 5,000 UNITS/ML | 0.0 | HEPARIN SODIUM | HEPARIN SODIUM | True |