Instant Report
FDF

The FDA (Food & Drug Administration) Orange Book is a database of drugs and pharmaceuticals that have been approved as both safe and effective by the U.S. Food and Drug Administration (FDA). Its official name is Approved Drug Products with Therapeutic Equivalence Evaluations & commonly it is known as the Orange Book.

The drugs included in orange book are not only approved as safe but are also proved to be effective. Drugs whose safety or efficacy approval has been withdrawn are not added in the Orange Book or they are removed after the withdrawal if they were added to the FDA (Food & Drug Administration) Orange Book.

A product can be added to the FDA (Food & Drug Administration) Orange Book if it is safe & effective & its application for approval has not been withdrawn for safety or efficacy reasons.

The Orange Book is divided into 4 parts described as under:

  • Approved over-the-counter (OTC) drug products
  • Prescription drug products which are already approved.
  • Pharmaceutical drug products approved under Section 505 of the FD&C Act.
  • Pharmaceutical drug products approved under Section 505 of the FD&C Act.

FDA (Food & Drug Administration) Orange Book is a freely accessible database prepared & maintained by the FDA describing all pharmaceutical drugs that have been proven both safe and effective. The Orange Book helps in finding generic drug substitutes for the branded pharmaceutical drugs, which may lower the cost of treatment for the patients. Only those drugs which have already cleared phase 3 clinical trials are added to the FDA (Food & Drug Administration) Orange Book database.

The FDA (Food & Drug Administration) Orange Book also includes catalogues of both prescription and OTC drug products by applicant name and brand name or by established name of the active ingredient if no brand name exists.

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