The Orange Book Electronic

Source DHHS, FDA, Center for Drug Evaluation and Research The Electronic Orange Book-Dec. 2003 Approved Drug Products with Therapeutic Equivalence Evaluations. 

The Electronic Orange Book Approved Drug Products with Therapeutic Equivalence Evaluations. US Department of Health and Human Services, PubUc Health Service, Food and Dmg Administration, Center for Dmg Evaluation and Research (CDER), Office of Information Technology, Division of Data Management and Services. http //www. fda.gov/cder/ob/default.htm... 

The Electronic Orange Book home page also provides access to a separate list of approved orphan drugs and, under its Preface link, a downloadable PDF version of cumulative patent and exclusivity lists and updates. 

The Orange Book is available electronically at http //www. fda.gov/cder/ob/default.htm . The Electronic Orange Book can be searched by active ingredient, proprietary name, applicant holder name, applicant number, or patent. The drug lists are arranged by active ingredient in alphabetical order. Discontinued products are published also. 

The FDA maintains a database of approved excipients Drug Information Electronic Orange Book, http //www.fda.gov/cder/ob/default.htm). Standards and tests for regulatory acceptable excipients are included in the US Pharmacopoeia and National Formulary. Two such tests, dissolution and stability, are included in Exhibit 5.12 for reference. For new excipients to be included in a drug formulation, they have to satisfy one of the following criteria ... 

FDA Electronic Orange Book http //www.fda.gov/cder/ob/default.htm Up-to-date information on all drug approvals and withdrawals in the US. Includes applicant, dosage form, proprietary name, date approved, patent information. Does not include drug label information or safety information. 

Note. 2005 sales of proprietary drugs loosing patent protection during the 2007-2012 period Sources MedAdNews 39-42 (June 2006) FDA Electronic Orange Book. 

The relevant data exclusivity periods for each approved drug product, as well as any applicable patents on the product or its use, are listed in the Orange Book , which is published by the FDA and also available electronically on the FDA s web site. 

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