what is the orange book 
the orange book is a list of drugs and pharmaceuticals that the u s food and drug administration fda has approved as both safe and effective although it is commonly called the orange book its formal name is approved drug products with therapeutic equivalence evaluations the orange book does not include drugs only approved as safe they must also have been proven to be effective drugs whose safety or efficacy approval has been withdrawn are excluded from the orange book however a drug that is currently subject to regulatory action may still appear in the orange book understanding the orange bookthe fda approves new drugs or existing drugs for new uses following a series of double blind randomized clinical trials early phases of this process involve tests to judge the safety of a compound to make sure it does not cause severe side effects or harm phase 3 trials are conducted on larger samples to prove both safety and efficacy against a placebo 2 if successful the drug will be added to the orange book and approved for use the orange book is available online for free this makes it easy for medical professionals to search for generic equivalents to brand name drugs drug patents and drug exclusivity consumers can also access the orange book online both patients and doctors can see approved uses for drugs and patent expiration dates for name brand drugs a doctor or patient can see if there is a generic equivalent to a brand name drug by doing an active ingredient search for prozac you would search the orange book for fluoxetine hydrochloride to be able to market and sell a generic drug the generic drugmaker must file an abbreviated new drug application anda with the food and drug administration fda the drugmaker must prove that the drug is bioequivalent to the brand name drug if an abbreviated new drug application anda is approved the generic drug will be listed in the orange book 3using the orange bookfor example a search for the prescription antidepressant drug prozac shows that the drug is available in different forms capsules tablets solutions delayed release pellets etc and it is also available in varying dosage strengths this search also reveals that five forms of the drug have been discontinued although in three instances it has been noted that the product was not discontinued or withdrawn for safety or efficacy reasons the capsules were first approved in 1987 and the drug is approved for acute treatment of treatment resistant depression in adults 4the orange book also shows that the drug s active ingredient is fluoxetine hydrochloride which may be generically available at a lower cost 5patent information