Orange Book by FDA PDF

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Orange Book by FDA

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.

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