Orange Book by FDA PDF

Orange Book by FDA PDF Download

Orange Book by FDA PDF download link is available below in the article, download PDF of Orange Book by FDA using the direct link given at the bottom of content.

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Orange Book by FDA PDF

Orange Book by FDA PDF Download for free using the direct download link given at the bottom of this article.

The Orange book by FDA was distributed among different medical organizations as a proposal in January 1979. Under the provision of Section 505 of the FD &C Act, it includes only current marketed prescription drugs products that are approved by FDA through New drugs Application (NDA) and Abbreviated New Drugs Application (ANDAs).

Features of Orange Book by the FDA

  • It sets forth FDA’s evaluation that has been approved of therapeutic equivalence of drug products.
  • It comprises FDA’s advice to a practitioner, public, and the state regarding the selection of drugs.
  • The products, which are mentioned in the Orange book, are identified by the names of the holder of approval applicants, who may not be the manufacturer of the drugs.

General and Legal Policies

The Orange book by FDA contains advice and public information. It does not mandate the drugs that are dispensed, purchased, prescribed, or substituted for another. It also does not mandate the product that should be avoided.

To download the PDF file of Orange Book by FDA, you can follow the link given below.

Orange Book by FDA PDF Download Link

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