Orange Book App completely covers FDA's 'Approved Drug Products with Therapeutic Equivalence Evaluations' (a.k.a. The Orange Book) and Electronic Orange Book (a.k.a.EOB). This app is designed to help medical professionals find therapeutically equivalent generic drugs for brand name drugs.
Drug products that FDA considers to be therapeutically equivalent to other pharmaceutically equivalent products, i.e., drug products for which:
* there are no known or suspected bioequivalence problems. These are designated AA, AN, AO, AP, or AT, depending on the dosage form; or
* actual or potential bioequivalence problems have been resolved with adequate in vivo and/or in vitro evidence supporting bioequivalence. These are designated AB.
Drugs with TE code begin with B are considered not to be therapeutically equivalent to other pharmaceutically equivalent products and are excluded from this application.
FDA approved package insert will be retrieved directly from FDA resources when the official description of a drug product is available. The package insert generally includes:
* indication (what the drug is used for); who should take it;
* adverse events (side effects);
* instructions for uses in pregnancy, children, and other populations;
* safety information for the patient.
Orange Book and its owners are not affiliated with FDA. All information presented by the application is for educational purpose solely. Nothing on these applications should be taken to constitute professional advice or a formal recommendation and we exclude all representations and warranties relating to the content and use of these applications. Please visit www.sigmaphone.com or email to [email protected] for more information.