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  1. Approved Animal Drug Products (Green Book)

Animal Drugs @ FDA Explained

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Animal Drugs @ FDA is a searchable online database that includes most FDA-approved and conditionally approved animal drugs. Indexed animal drugs are not listed in Animal Drugs @ FDA.

At the top of the page, you can do either a quick search or an advanced search of the database using several parameters, including the drug's proprietary name (also known as the trade name or brand name), active ingredient, and application number. There are three types of animal drug applications, and each application has a six-digit application number. 

Supporting Documents

Animal Drugs @ FDA also includes various supporting documents for approved and conditionally approved animal drugs:

  • Environmental Documents—These documents include Environmental Assessments and Findings of No Significant Impact. You can search the documents by the established or chemical name of the drug’s active ingredient. For more information about these environmental documents, see Environmental Impact Considerations. 
  • FOI Summaries—The Freedom of Information (FOI) Summary provides the public with a summary of the key information that FDA used to determine that the NADA, ANADA, or CNADA met the requirements for approval or conditional approval. Most recent FOI Summaries include an Executive Summary that provides a brief overview of the scientific basis for the approval or conditional approval followed by a more detailed description. For more information about these summaries, see Freedom of Information (FOI) Summaries for Approved and Conditionally Approved Animal Drugs. 
  • NSAID Labels—This is a partial collection of the labels for currently approved nonsteroidal anti-inflammatory drugs (NSAIDs) for animals. You can search the labels by the active ingredient of the approved NSAID. For more information about these drugs, see Veterinary NSAIDs. 
  • Blue Bird Labels—This is a collection of representative labels (also called “Blue Bird” labels) for animal feed that contains an approved animal drug (called a medicated feed) for food-producing animals. A Bird Blue label is a template that is approved by FDA to help feed mills prepare the final printed label for a medicated feed. (A final printed label is the actual label that is attached to or included with the medicated feed container.) You can search the Blue Bird labels by animal group. For more information about these labels, see Blue Bird Labels. 

Green Book Reports

Green Book Reports are in the middle of the page. The Green Book is a list of most FDA-approved and conditionally approved animal drugs and includes information about patents and marketing exclusivity. While the information in the Green Book is mainly used by drug companies wanting to manufacture and distribute generic animal drugs, it is also a resource for the public. Indexed animal drugs are not listed in the Green Book. For more information about the Green Book, see Approved Animal Drug Products (Green Book).  

Medicated Feeds

At the bottom of the page, there are lists of feed mills that are licensed to manufacture certain categories of medicated feed for food-producing animals. There are also lists of distributors that have notified FDA that they distribute animal feed containing a veterinary feed directive (VFD) drug. For more information about medicated feeds and feed mill licensing, see Medicated Feeds. For more information about VFD drugs, see Veterinary Feed Directive (VFD). 
 

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