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Frequently Asked Questions

What information does the Orange Book provide about approved drugs?

The Orange Book provides information regarding whether each approved drug is a new drug application (NDA) or abbreviated new drug application (ANDA), and, where eligible, has patent and/or exclusivity information. Additionally, the Orange Book identifies an RLD – the drug to which the ANDA applicant must show its proposed generic drug is the same.

What is the Orange Book of therapeutic equivalence?

The Orange Book is the only official source for therapeutic equivalence evaluations and reference listed drug (RLD) data for FDA-approved generic and brand-name drugs. FDA evaluates approved multiple-source drugs for therapeutic equivalence and assigns a rating code which appears in the Orange Book.

What is not included in the Orange Book?

The Orange Book does not include: (1) approved drug products that were discontinued 101 either before the first edition in October 1980 or discontinued between 1980 and 1987, 102 prior to the identification of discontinued products; (2) drug products that have a tentative 8

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”.

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