What is Orange Book?
The publication Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act) and related patent and exclusivity information. For more information on the Orange Book including its history, see the Orange Book Preface.
The Orange Book was distributed as a proposal in January 1979. It included only currently marketed prescription drug products approved by FDA through new drug applications (NDAs) and abbreviated new drug applications (ANDAs)under the
provisions of Section 505 of the FD&C Act and FDA regulations at that time.
What is Red Book pharmacy?
The red book was first published October 7, 2009. The purpose of RED BOOK is to allow comprehensive access to current and accurate drug pricing and description information. Description. RED BOOK covers FDA-approved drug products. It includes prescription drugs, over-the-counter drugs, and nondrug products. “The Red Book” is the preeminent resource on pediatric infectious disease.
A “Red Book” valuation is designed to ensure that high standards of inspection, investigation, analysis, definitions, justification and presentation are met. The end product should therefore be a well considered and robust document that the intended parties can rely upon.
What is the Purple Book FDA?
The FDA has transitioned the Purple Book to a searchable, online database that contains information about biological products, including biosimilar and interchangeable biological products, licensed (approved) by the FDA under the Public Health Service (PHS) Act.
The “Purple Book” began as two lists (one for the CDER and one for CBER) that kept track of each Center’s licensed biological products. In February 2020, FDA released a searchable, online database that now replaces both lists because information about FDA-approved biological products is available in the Purple Book database.
