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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”.

What is an orange book Drug Code?

Every drug listed in the Orange Book has a 2-letter code. The first letter -- A or B -- indicates whether the drug is therapeutically equivalent to other pharmaceutically equivalent products.

Where can I find the Orange Book appendices?

[Updated] The Orange Book Appendices are available in PDF format. You can search by active ingredient, proprietary name, applicant, or application number. The active ingredient (s) for the product.

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