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# Orange Book Q&A Draft Guidance
- URL: https://www.fdaweb.com/orange-book-q-a-draft-guidance/
- Published: 2020-05-29T12:00:00.000Z
- Updated: 2026-09-14T16:16:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146895

FDA has issued a draft guidance, *Orange Book Questions and Answers* to help interested parties use the *Orange Book*. The [document](https://www.fda.gov/media/138389/download?ref=fdaweb.com) gives answers to commonly asked questions received from parties such as prospective drug product applicants, drug product applicants, and approved application holders.

The *Orange Book* identifies drug products approved by FDA under the Federal Food, Drug, and Cosmetic Act and patent and exclusivity information related to approved drug products. The draft says the main criteria for inclusion of a drug product in the *Orange Book* are that the product is the subject of an approved application and that FDA has not determined that the product has been withdrawn from sale for safety or effectiveness reasons.