What Is the Orange Book?

The Orange Book is a list of drugs that have been approved as safe and effective drugs by the United States Food and Drug Administration (FDA). Although commonly referred to as the Orange Book, its official name is an Approved Medicinal Product with a Therapeutic Equivalence Assessment.

The US FDA Orange book search does not contain drugs that are only approved as safe drugs (they must also be proven effective). Medicines for which safety or efficacy approval has been withdrawn are excluded from the orange book. However, drugs that are currently subject to regulations may still appear in the Orange Book.

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Orange Book is available online for free. This makes it easier for medical professionals to search for generic equivalents of brand-name drugs, drug patents, and drug exclusivity. Users can also access the Orange Book online. Both the patient and doctor can see the approved drug use and expiration date on the patent for a particular drug.

For example, a search for the antidepressant Prozac prescription reveals that it is available in different dosage forms (capsule, tablet, solution, slow-release granules) and also in different strengths. The search also found that five forms of the drug had been withdrawn, although three cases found that the product was not withdrawn or withdrawn for safety or efficacy reasons.

The orange book also shows that the active ingredient in the drug is fluoxetine hydrochloride. Capsules were first approved in 1987, and the drug was approved for the acute treatment of treatment-resistant depression in adults.