Orange Book

Approved Drug Products with [therapeutic equivalence|Therapeutic Equivalence]] Evaluations.

Approved Drug Products With Therapeutic Equivalence

These evaluations by the US FDA identify drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA).

Criteria

• The main criterion for the inclusion of any product is that the product is the subject of an application with an approval that has not been
• withdrawn for safety or effectiveness reasons.
• Inclusion of products in the Orange Book is independent of any current regulatory action being taken administratively or judicially against a drug product.
• In addition, the Orange Book contains therapeutic equivalence evaluations for approved multisource prescription drug products.
• These evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the area of drug product selection and to foster containment of health care costs.

External

• FDA orange book
• 42nd annual edition
• Orange book
• Orange book archives

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