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  5. Resources for Information | Approved Drugs
  1. Drug Approvals and Databases

Resources for Information | Approved Drugs

Includes information about drugs approved for human use in the United States:

  • Drug information,
  • Regulatory history,
  • Most recent FDA-approved Prescribing Information and patient labeling, and
  • Reviews by FDA staff that evaluate the safety and effectiveness of the drug.

Drugs@FDA does not include information about FDA-approved products regulated by the Center for Biologics Evaluation and Research (vaccines, allergenic products, blood and blood products, plasma derivatives, and cellular and gene therapy products) or products not approved by the FDA. More about Drugs@FDA

FDA’s Labeling Resources for Human Prescription Drugs
Includes searchable labeling and product databases and explains how “current” labeling that is submitted by companies to the FDA (e.g., labeling that appears on DailyMed and FDALabel) may differ from the last FDA-approved labeling (labeling that appears on Drugs@FDA). This webpage also links to the following additional prescription drug labeling-related resources:

  • The Prescribing Information Resources webpage includes a sample template for the Prescribing Information and specific resources for each section of the Full Prescribing Information.
  • The Patient Labeling Resources webpage includes answers to questions about Instructions for Use, Medication Guides, and Patient Package Inserts.
  • The Carton and Container Labeling Resources webpage includes carton and container labeling regulatory provisions, guidances, and MAPPs.
  • The Generic Drugs – Specific Labeling Resources webpage includes information about requirements for generic drug labeling, recommendations on updating generic drug labeling, and generic drug labeling guidances and MAPPs.
  • The Biological Products – Specific Labeling Resources webpage includes biosimilar and interchangeable biosimilar guidances, the “deemed BLA” guidance, and nonproprietary biological product nomenclature guidances and MAPPs.
  • The Selection of Appropriate SPL Codes for Human Prescription Drug Labeling webpage includes recommendations for Structured Product Labeling developers in selecting the appropriate SPL codes for human prescription drug labeling.
  • The Frequently Asked Questions about Labeling for Prescription Medicines includes prescription drug labeling resources for healthcare professionals and patients.

Orange Book

The publication, Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), identifies 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 (the Act).  The main criterion for the inclusion of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons.  In addition, the Orange Book contains therapeutic equivalence evaluations for approved multisource prescription drug products. FAQs on the Orange Book

Purple Book Database

The “Purple Book” is available both as lists and a searchable, online database that contains information about biological products, including biosimilar and interchangeable biological products, licensed (approved) by the FDA under the Public Health Service (PHS) Act. Currently, the lists contain information about all FDA licensed biological products. The new, searchable database contains information about a limited number of FDA-licensed biological products: licensed biosimilar and interchangeable products, and their reference products.

Additional Resources

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