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The Code of Federal Regulations of the United States of America
The Code of Federal Regulations is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government.
Federal Register
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Approved Drug Products with Therapeutic Equivalence Evaluations - FDA Orange Book 28th Edition (2008)
FDA Orange Book 28th Edition - 2008 (Approved Drug Products With Therapeutic Equivalence Evaluations)
Approved Drug Products with Therapeutic Equivalence Evaluations - FDA Orange Book 31st Edition (2011)
FDA Orange Book 31st Edition - 2011 (Approved Drug Products With Therapeutic Equivalence Evaluations)
Approved Drug Products with Therapeutic Evaluations
Identifies drug products approved on the basis of safety & effectiveness by the FDA under the Federal Food, Drug, & Cosmetic Act. Composed of 4 parts: approved prescription drug products with therapeutic equivalence evaluations; over-the-counter (OTC) drug products that require approved applications as a condition of marketing; drug products with approval under Sect. 505 of the Act; & products that have never been marketed, have been discontinued from marketing, or that have had their approvals withdrawn for other than safety or efficacy reasons.
