is a Data Source.
The FDA Orange Book, Approved Drug Products with Therapeutic Equivalence Evaluations, identifies drug products approved on the basis of safety and effectiveness by FDA and provides therapeutic equivalence, patent, and exclusivity information.
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| ID | Name | URL | Category | Format | Description |
|---|---|---|---|---|---|
| fda-orange-book.search | FDA Orange Book Search | default.htm | GraphicalInterface | ❔ | FDA searchable Orange Book database f... |
| fda-orange-book.data-files ⚠ | FDA Orange Book Data Files | orange-book-data-files | Product | mixed | FDA Orange Book data files and append... |
| fda-orange-book.preface ⚠ | FDA Orange Book Preface | orange-book-preface | DocumentationProduct | ❔ | FDA Orange Book preface describing pu... |
| ID | Name | URL | Category | Format | Relation | Description |
|---|---|---|---|---|---|---|
| medi.orangebook | MeDI Orange Book Extract | orangebook.xlsx (902.6 KB) | Product | ❔ | was derived from | FDA Orange Book regulatory source ext... |
The FDA Orange Book is the authoritative FDA publication for approved drug products with therapeutic equivalence evaluations. It provides search and data file access to product approval, therapeutic equivalence, patent, and exclusivity information used by downstream regulatory and drug indication resources.
Created: June 02, 2026 | Last modified: June 03, 2026