1.

What Is Orange Book?

Answer»

It is the commonly used name for the book “Approved Drug Products with Therapeutic Equivalence Evaluations”, which is PUBLISHED by USFDA.

It CONTAINS the list of 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.

It is the commonly used name for the book “Approved Drug Products with Therapeutic Equivalence Evaluations”, which is published by USFDA.

It contains the list of 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.



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