Orange Book

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Definition of 'Orange Book'

The Orange Book is a publication of the United States Department of Health and Human Services (HHS) that provides information on the effectiveness and safety of prescription drugs. The Orange Book is named for its distinctive orange cover.

The Orange Book is divided into two sections: the "Approved Drug Products with Therapeutic Equivalence Evaluations" section and the "Approved Drug Products with Therapeutic Equivalence Evaluations for Over-the-Counter Human Drugs."

The "Approved Drug Products with Therapeutic Equivalence Evaluations" section lists all prescription drugs that have been approved by the Food and Drug Administration (FDA). The section also includes information on the drug's active ingredients, dosage forms, strengths, and indications.

The "Approved Drug Products with Therapeutic Equivalence Evaluations for Over-the-Counter Human Drugs" section lists all over-the-counter drugs that have been approved by the FDA. The section also includes information on the drug's active ingredients, dosage forms, strengths, and indications.

The Orange Book is an important resource for healthcare professionals, pharmacists, and consumers. The Orange Book provides information on the safety and effectiveness of prescription drugs, and it can be used to help make informed decisions about drug therapy.

The Orange Book is available online at the HHS website.

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