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Frequently Asked Questions

What is the Orange Book?

Preface to the 41st Edition The publication, Approved Drug Products With Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book), identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

What is a reference standard in the Orange Book?

In the electronic Orange Book, a reference standard is identified by “RS” in the RS column. The group or category of approved drugs. Format is RX, OTC, DISCN. The full name of the firm holding legal responsibility for the new drug application. The type of new drug application approval. New Drug Applications (NDA or innovator) are ”N”.

Does the Orange Book contain therapeutic equivalence 6?

5 65 66 In addition, the Orange Book contains therapeutic equivalence 6 evaluations for approved 67 multisource prescription drug products , which are reflected for drug products in the Active 68 Section. 7 These evaluations have been prepared to serve as public information and advice to 4 See 21 CFR 314.161. 5

Where can I find information about the FDA Orange Book?

information to the FDA Recognize the statutory requirements for the movement of drug products between the active and discontinued sections of the Orange Book and the Orange Book timing for publication Employ the Orange Book website to locate relevant regulatory information www.fda.gov 5


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