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FDA Product Tracking and Submission History
Data Science and Analytics
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About
This collection explains drug data tracked by the United States Food and Drug Administration (FDA), capturing details on nearly every drug the agency has encountered starting from 1939. Derived from the OpenFDA Drug API, this essential resource provides vital insights into the history of drug regulation, approval sponsors, and market availability. The data is kept current through a scheduled weekly refresh.
Columns
- application_number: The unique regulatory identification number assigned to a drug submission.
- sponsor_name: Identifies the drug manufacturer or applicant, with examples including WATSON LABS and HIKMA.
- brand_name: The commonly recognised name of the product, such as PREGABALIN.
- product_number: Relates to the label count associated with the product.
- reference_drug: A boolean field indicating if the product serves as a reference drug.
- active_ingredients: Describes the chemical components actually contained within the drug, often listing specific concentrations (e.g., CLOBETASOL PROPIONATE (0.05%)).
- referenced_standard: A boolean field indicating if the drug meets a referenced standard.
- dosage_form: Defines the physical format in which the drug is administered, with common forms being TABLET and INJECTABLE.
- route: Describes the method by which the drug is taken by a person, such as ORAL or INJECTION.
- marketing_status: Indicates the current market standing, often recorded as Prescription or Discontinued.
Distribution
The information is available in flat-file formats, primarily CSV. The core dataset includes two main files:
drugs.csv, detailing drugs and their manufacturers, and submissions.csv, outlining New Drug Applications and supplemental submissions. The main drug file contains 10 columns and roughly 50.2 thousand valid records. The original information obtained from the FDA is also provided in JSON format.Usage
This data is ideal for analysing drug approval timelines and historical market trends. It supports investigations into how drug components (active ingredients) correlate with different administration routes or dosage forms. It can also be used to track which manufacturers dominate specific areas of the pharmaceutical market and monitor changes in a product's marketing status over time.
Coverage
The scope covers products tracked by the United States FDA. The time range extends historically from 1939 right up to the present day. The data is routinely updated every week (on Wednesdays EST).
License
CC0: Public Domain
Who Can Use It
- Public Health Researchers: To study the long-term availability and discontinuation rates of vital medications.
- Data Analysts: To build predictive models for drug submissions or market success based on sponsor patterns.
- Pharmaceutical Professionals: To monitor competitor activity and reference drug standards.
Dataset Name Suggestions
- United States FDA Drug Register (1939-Present)
- FDA Product Tracking and Submission History
- Weekly US Drug and Manufacturer List
Attributes
Original Data Source: FDA Product Tracking and Submission History
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