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  1. Drug Approvals and Databases

Drugs@FDA Data Files

January 10, 2025. Database Update: Linking Submissions and Action Types
To improve the relational structure of the database, a new linking table (Join_Submission_ActionTypes_Lookup) has been introduced to establish a relationship between the Submissions table and the Action Types table.
Purpose:
This linking table will facilitate the connection between individual submissions and the different types of actions associated with them, allowing for greater flexibility in querying and reporting.

Below you will find a compressed data file of the Drugs@FDA database. It does not include the scripts (programming) we use to produce the online version of Drugs@FDA. We are providing this technical information for users who are familiar with working with databases or spreadsheets. All fields are separated by tab delimiters. Each table's primary key, data types, field lengths and nulls appear in the list below. While the official online application, Drugs@FDA, is updated daily, this data file is updated once per week, on Tuesday.

Once you have downloaded the compressed file (drugsatfda.zip), you can unzip the file into 11 text tables. You can then import the tables into a database, spreadsheet or word processing program. Generally, a database program is the best program to use for these types of files.

We cannot offer guidance on how to construct your database design, as each user has different requirements or uses.

Download File

Data Definitions and ERD for Drugs@FDA (as of January 10, 2025)

Entity Relationship Diagram

Drugs@FDA ERD Diagram Small Version

Drugs@FDA consists of 12 tables:

ActionTypes_Lookup

  • [ActionTypes_LookupID] [int] IDENTITY(1,1) NOT NULL
  • [ActionTypes_LookupDescription] [varchar](100) NOT NULL
  • [SupplCategoryLevel1Code] [varchar](100) NULL
  • [SupplCategoryLevel2Code] [varchar](100) NULL

ApplicationDocs

  • [ApplicationDocsID] [int] IDENTITY(1,1) NOT NULL
  • [ApplicationDocsTypeID] [int] NOT NULL
  • [ApplNo] [char](6) NOT NULL
  • [SubmissionType] [char](10) NOT NULL
  • [SubmissionNo] [int] NOT NULL
  • [ApplicationDocsTitle] [varchar](100) NULL
  • [ApplicationDocsURL] [varchar](200) NULL
  • [ApplicationDocsDate] [datetime] NULL

Applications

  • [ApplNo] [char](6) NOT NULL
  • [ApplType] [char](5) NOT NULL
  • [ApplPublicNotes] [text] NULL
  • [SponsorName] [char](500) NULL

ApplicationsDocsType_Lookup

  • [ApplicationDocsType_Lookup_ID] [int] IDENTITY(1,1) NOT NULL
  • ApplicationDocsType_Lookup_Description] [varchar](200) NOT NULL

Join_Submission_ActionType_Lookup (NEW) 

  • J_SubmissionActionTypeID [int] IDENTITY(1,1) NOT NULL
  • SubmissionNo [int] NOT NULL
  • SubmissionType [char](10) NOT NULL
  • ApplNo [char](6) NOT NULL
  • ActionTypes_LookupID [int] NOT NULL

MarketingStatus

  • [ApplNo] [char](6) NOT NULL,
  • [ProductNo] [char](3) NOT NULL,
  • [MarketingStatusID] [int] NOT NULL

MarketingStatus_Lookup

  • [MarketingStatusID] [int] IDENTITY(1,1) NOT NULL
  • [MarketingStatusDescription] [varchar](200) NOT NULL

Products

  • [ApplNo] [char](6) NOT NULL
  • [ProductNo] [char](6) NOT NULL
  • [Form] [varchar](255) NULL
  • [Strength] varchar](240) NULL
  • [ReferenceDrug] [int] NULL
  • [DrugName] [varchar](125) NULL
  • [ActiveIngredient] [varchar](255) NULL
  • [ReferenceStandard] [int] NULL

SubmissionClass_Lookup

  • [SubmissionClassCodeID] [int] IDENTITY(1,1) NOT NULL
  • [SubmissionClassCode] [varchar](50) NOT NULL
  • [SubmissionClassCodeDescription] [varchar](500) NULL

SubmissionPropertyType

  • [ApplNo] [char](6) NOT NULL
  • [SubmissionType] [char](10) NOT NULL
  • [SubmissionNo] [int] NOT NULL
  • [SubmissionPropertyTypeCode] [varchar](50) NOT NULL (Orphan or NULL)
  • SubmissionPropertyTypeID [int] NOT NULL

Submissions

  • [ApplNo] [char](6) NOT NULL
  • [SubmissionClassCodeID] [int] NULL
  • [SubmissionType] [char](10) NOT NULL
  • [SubmissionNo] [int] NOT NULL
  • [SubmissionStatus] [char](2) NULL
  • [SubmissionStatusDate] [datetime] NULL
  • [SubmissionsPublicNotes] [text] NULL
  • [ReviewPriority] [varchar](20) (Standard, Priority, NULL)

TE

  • [ApplNo] [char](6) NOT NULL
  • [ProductNo] [char](3) NOT NULL
  • [MarketingStatusID] [int] NOT NULL
  • [TECode] [varchar](100) NOT NULL

 

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