The U.S. Food and Drug Administration (FDA) publishes Drugs@FDA, a public resource containing information about drugs, including biological products, approved for human use in the United States. For healthcare data users, Drugs@FDA connects drug applications with products, submissions, regulatory actions, and related information.
The key to using this information correctly is understanding the record structure. An application is not the same as a product, and a product is not the same as a submission. A submission status date belongs to that specific submission record—not automatically to every product or event associated with the application.
QOPE brings selected public healthcare datasets into a more accessible environment. Its FDA Approvals dataset includes application number, product number, submission number, submission type, action date, approval status, sponsor, dosage form, route, and strength.
Table of contents
- What Drugs@FDA Contains
- How the FDA Data Model Separates Applications, Products, and Submissions
- What the Main Fields Mean
- Worked Example: Reading One Submission Record
- How Healthcare Data Users Can Apply the Dataset
- Important Interpretation Limits
- Frequently Asked Questions
- Related QOPE Guides
What Drugs@FDA Contains
Drugs@FDA records approval information for drug applications. The official resource allows users to search by drug name, active ingredient, or application number. It also provides regulatory information and, for prescription brand-name drugs, typically includes the most recent FDA-approved labeling and FDA staff reviews evaluating safety and effectiveness when available.
The resource covers drugs and certain biological products approved for human use in the United States. It does not include FDA-approved products regulated by the Center for Biologics Evaluation and Research, such as vaccines, allergenic products, blood and blood products, plasma derivatives, and cellular and gene therapy products.
That scope matters for international data users. Drugs@FDA is a U.S.-specific regulatory resource, not a global register of medicines, approvals, or marketing authorizations. A product’s absence from Drugs@FDA may reflect the resource’s scope rather than a conclusion about its regulatory status elsewhere.
The FDA also publishes downloadable Drugs@FDA data files for users familiar with databases or spreadsheets. The files use tab delimiters and can be imported into a database, spreadsheet, or word-processing program. The published structure contains 12 text tables, with definitions for primary keys, data types, field lengths, and null values.
How the FDA Data Model Separates Applications, Products, and Submissions
The most important structural distinction is that product and submission records are stored in distinct tables.
The Applications table identifies an application through ApplNo, along with application type, sponsor name, and public notes. The application number is a central reference for connecting related records.
The Products table contains product-level information linked to the application number and product number. Its fields include drug name, active ingredient, form, strength, reference-drug information, and reference-standard information. In a QOPE view, these concepts correspond to fields such as dosage form and strength.
The Submissions table contains submission-level information. Its fields include application number, submission type, submission number, submission status, submission status date, public notes, submission class, and review priority.
This separation prevents a common analytical mistake: treating an application, product, and submission as interchangeable. One application can be associated with multiple products and multiple submissions. Each submission may represent a different regulatory event or filing associated with the application.
The submission number and submission type should be read together with the application number. A submission status date is not a general date for the entire application; it is the date recorded for that particular submission.
The data files also include lookup and linking tables. For example, action types connect to submissions through Join_Submission_ActionType_Lookup, while marketing status values are represented through MarketingStatus and MarketingStatus_Lookup. These relationships help distinguish product marketing information from the status of a specific submission.
What the Main Fields Mean
A practical reading usually begins with the identifiers:
- Application number (
ApplNo): identifies the application. - Product number (
ProductNo): identifies a product associated with an application. - Submission number (
SubmissionNo): identifies a particular submission associated with an application. - Submission type: indicates the type assigned to the submission.
- Action date: records the date associated with a regulatory action in the relevant approval information.
- Approval status: describes the status presented for the relevant approval or regulatory record.
- Sponsor: identifies the sponsor name recorded for the application.
- Dosage form: describes the product form represented in the product record.
- Route: identifies the administration route where provided in the structured dataset.
- Strength: records the product strength.
The identifiers are useful for joining records, tracing relationships, and avoiding ambiguity. They do not, by themselves, explain the full regulatory history or clinical context. Users should consult the original FDA record and associated materials when official verification is required.
The FDA’s monthly approval reports also have defined scope. They include BLAs, NDAs, and ANDAs—or supplements to those applications—approved by the Center for Drug Evaluation and Research (CDER), along with tentative NDA and ANDA approvals in CDER. They do not include applications or supplements approved by the Center for Biologics Evaluation and Research (CBER).
Worked Example: Reading One Submission Record
Consider a single submission-level record with these values:
ApplNo:000006SubmissionType:ORIGSubmissionNo:1SubmissionStatus:APSubmissionStatusDate:1982-01-01ReviewPriority:Standard
Here is how to read it carefully.
First, 000006 identifies the application and can connect this submission to the corresponding application and related product records.
Second, ORIG is the recorded submission type. Together with submission number 1, it identifies the particular submission being described: the first submission of that recorded type for application 000006.
Third, AP is the value stored in the submission-status field. The status should be interpreted using the dataset’s defined terminology and the surrounding FDA record, rather than treated as a free-standing conclusion detached from the application.
Fourth, 1982-01-01 is the SubmissionStatusDate. It belongs to this specific submission record. It should not automatically be copied to every product connected with application 000006 or presented as the date of every later action associated with that application.
Finally, Standard is the recorded review-priority value for this submission.
What does this record tell you? It identifies an application, a particular original submission, its recorded status, the date attached to that submission status, and its review-priority value.
What does it not tell you by itself? It does not provide the drug name, active ingredient, dosage form, or strength. Those are product-level details found by following the application and product relationship. It also does not provide the complete history of the application. Other submissions may exist with different numbers, types, statuses, dates, or notes. To understand the broader record, read the linked application, product, submission, action-type, and marketing-status information together.
This example illustrates why field-level interpretation matters. A date is meaningful only when its table and record context are preserved. A submission status is not automatically a product status, and an application identifier is not a substitute for reviewing associated records.
How Healthcare Data Users Can Apply the Dataset
Researchers can use application and product identifiers to organize regulatory information across related records. A product-focused analysis may begin with drug name, active ingredient, dosage form, route, and strength, then use application and product numbers to connect those attributes to the relevant application.
Regulatory and market-access teams may examine submission types, action dates, review priority, and status fields to understand how records are structured over time. Data engineers can use the published keys and lookup tables to build joins while preserving the distinction between application-level, product-level, and submission-level information.
The dataset can also support careful reconciliation. For example, a user may compare a product’s marketing-status record with a submission record, but the two should not be collapsed into one field or event. Marketing status is represented separately from submission status, and that relationship should remain explicit in downstream analysis.
For current file listings and update information, check the FDA’s Drugs@FDA data-files page. That page states that the downloadable file is updated each morning, Monday through Friday, and displays a current “Data Last Updated” date. Because those details can change, confirm the date on the FDA page when downloading or citing the files.
QOPE helps users explore structured public healthcare data, including fields that make application, product, and submission relationships easier to review. Users should consult the original public source when official verification is required. You can also Browse all QOPE databases to see other organized public healthcare datasets.
Important Interpretation Limits
Drugs@FDA is a source of U.S. drug-approval information, but it must be read within its documented scope. Coverage does not extend to every FDA-regulated biological product, and the data files are structured for users who can work with database or spreadsheet formats.
A listed record should be interpreted according to its table, identifier, field definition, and relationship to other records. In particular, do not treat every submission shown in an application’s history as an approved submission. Approval reports distinguish approvals from tentative approvals and define which application types and FDA centers are included.
Regulatory records also require attention to time. A status or date is a value recorded for a particular record at a particular point in the published data. Do not assume that an approval status is permanently unchanged; check the current official record when status matters to a decision.
Frequently Asked Questions
What Is Drugs@FDA?
Drugs@FDA is an FDA resource containing information about drugs, including biological products, approved for human use in the United States. It includes regulatory information and may include labeling and FDA staff reviews for prescription brand-name drugs.
Are Applications, Products, and Submissions the Same Thing?
No. Applications, products, and submissions are represented in distinct tables and have different identifiers and fields. They should be connected through their documented relationships.
What Does a Submission Status Date Represent?
A submission status date belongs to the specific submission record identified by its application number, submission type, and submission number. It is not automatically a date for every product or event linked to the application.
Where Should I Verify an FDA Record?
Use the original Drugs@FDA resource and FDA data-files page for official verification, current file information, and the underlying record context.
Related QOPE Guides
- FDA Approvals: How to Research Drugs@FDA Records and Approval Dates
- FDA Orange Book: A Practical Guide to Drug Listings, Therapeutic Equivalence, Patents, and Exclusivity
- FDA Orphan Drug Designations: What Public Data Shows About Rare Disease Drug Incentives
- How to Read FDA Adverse Event Data Without Inferring Causation
- Browse all QOPE databases
QOPE is not affiliated with CMS, the FDA, or any government agency. QOPE organizes selected public healthcare data and does not replace official sources.