Orange Book by FDA - Summary
The Orange Book by FDA is a crucial PDF resource for anyone who wants to learn about approved prescription drugs in the United States. Originally introduced in January 1979, this book contains a comprehensive list of current marketed prescription drug products that have received FDA approval through New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDAs).
Important Features of the Orange Book
Key Highlights
- It provides FDA’s assessment of the therapeutic equivalence of various drug products.
- It offers guidance to healthcare practitioners, the public, and state agencies on drug selection.
- The products listed in the Orange Book are identified by the names of the approval holders, who may not always be the actual manufacturers of the drugs.
General and Legal Policies
The Orange Book by FDA acts as a trusted source of information and does not enforce any specific requirements on the drugs that can be dispensed, purchased, prescribed, or substituted. It also does not suggest which products should be avoided.
To download the PDF file of the Orange Book by FDA, simply follow the link provided below. Remember, this PDF download is a valuable tool for gaining insights into approved prescription medications. 📄
