fda-orange-book-query

What problem does it solve?

Provides programmatic access to FDA Orange Book data to identify approved drug products, their bioequivalence status, patent and exclusivity information, and sponsor details.

Core Features & Use Cases

• REST API access to FDA Orange Book data (openfda) for brand and generic names, approvals, sponsors, and product details.
• Example-driven guidance and offline fixtures to validate retrieval patterns when network access is limited.
• Use cases include researching product approvals, patent status, and sponsor information for drug knowledge tasks or QA workflows.

Quick Start

Run the paired script 65_FDA_Orange_Book.py to reproduce the workflow and retrieve brand and generic names, application numbers, and sponsor details for a given drug.