Peptency Academy · Guide
Reading Drugs@FDA application history
How can an application number be searched and its approval documents read in Drugs@FDA?
US
Drugs@FDA is an FDA database that provides approval history, including approval letters and FDA reviews. For an application-number search, enter all three to six digits, read its application identity, approval letters and dates together. Source sentence
FAQ1 approval history; FAQ5 typical regulatory fields and approval letters/dates; FAQ7 application search requires all three to six digits; FAQ8 selecting a specific application.1 FDA: Drugs@FDA frequently asked questions
Regulatory content shown for: United States and the Americas.
GuidesAcademyGuideGuides
Known, not known, contested
US
Known
- FDA states that Drugs@FDA includes most drug products approved since 1939 and that the database is updated daily. Source sentence
About Drugs@FDA, coverage paragraph and Update frequency, lines 63 to 67.
2 FDA: About Drugs@FDA
Not known
- A missing search result does not establish illegality: FDA lists approved products outside this database, including vaccines and other products regulated by its biologics centre. Source sentence
FAQ 3, approved products excluded from Drugs@FDA; inference limited to database coverage.
1 FDA: Drugs@FDA frequently asked questions
Contested
Nothing listed yet.
Record fields
US
- Application and sponsor
- Read the application type and number together: FDA lists NDA, ANDA and BLA as application types and identifies the company sponsoring the application. Source sentence
FAQ 5, Regulatory information, application type, application number and company.
1 FDA: Drugs@FDA frequently asked questions - Application-number search
- The FDA FAQ specifies that an application-number search must contain all the digits, with three to six digits entered. It also states that an application number cannot be combined with a drug or ingredient name in the same search. Source sentence
FAQ7, application number searches, lines167 to187.
1 FDA: Drugs@FDA frequently asked questions - Dates and labels
- Keep approval dates and approval letters separate from the latest and previously approved labeling listed for the product. Source sentence
FAQ 5, labeling and Regulatory information field lists.
1 FDA: Drugs@FDA frequently asked questions
Reading sequence
US
- Start with the main search box, which accepts a drug name, active ingredient or application number, rather than regarding an alphabetical name browse as a complete ingredient search. The search page also separates original approvals, supplemental approvals and tentative approvals in its monthly report menus. Source sentence
Search heading and Browse by Drug Name, lines 51 to 58; main search inputs are distinct from alphabetical browsing. Monthly report choices, lines 59 to 75. FAQ 6 explains that alphabetical drug-name results do not include all other products containing that ingredient.
3 FDA: Drugs@FDA search1 FDA: Drugs@FDA frequently asked questions - Open the named search result and select a specific application before recording the product fields and history. FDA describes this selection sequence in its FAQ. Source sentence
FAQ 8, select drug name on Search Results, then specific application number.
1 FDA: Drugs@FDA frequently asked questions - The FDA FAQ describes the listed regulatory fields and documents as typically available. Source sentence
FAQ5, introductory qualifier: the following information is typically available for a product in Drugs@FDA; lines109 to128.
1 FDA: Drugs@FDA frequently asked questions
US
The FDA FAQ lists application type, application number, sponsoring company, approval letters and approval dates among the regulatory information typically available. Record the type, number and company with the selected application, then keep its approval letters and approval dates distinct from the latest and previously approved labeling. Source sentence
FAQ5 typical regulatory information and labeling; interpretation separates the listed fields rather than treating labels and approval letters as identical.1 FDA: Drugs@FDA frequently asked questions
Sources
- 1FDA: Drugs@FDA frequently asked questions accessed 16 Oct 2026
- 2FDA: About Drugs@FDA accessed 16 Oct 2026
- 3FDA: Drugs@FDA search accessed 16 Oct 2026
About this page
Research-use information. This library summarises published literature and regulator records. It is not guidance for use, not medical advice, and not a statement that any material is suitable for use in people or animals.
Reviewed by the Peptency editorial process. Version 1, last edited 16 October 2026, 3 sources.
Cite this page: Peptency Academy. Reading Drugs@FDA application history. Version 1./us/academy/guides/us-drug-approval-records/