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        Products

Approved Animal Drug Products (Green Book)

                        
                Freedom of Information (FOI) Summaries for Approved and Conditionally Approved Animal Drugs
          Recent Animal Drug Approvals


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          Approved Animal Drug Products (Green Book)Products Approved Animal Drug Products (Green Book)
  	
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    PrintMost FDA-approved animal drugs are included in a publicly available list of approved animal drug products. This list is called the Green Book for short, and FDA updates it in its entirety every month. You can find these monthly updates on Animal Drugs @ FDA.

The Generic Animal Drug and Patent Restoration Act of 1988 required that FDA establish and publish the Green Book and that animal drug companies submit certain information to FDA about patents and marketing exclusivity to be included in the Green Book. Brand name animal drugs that aren’t protected by patent or marketing exclusivity are eligible to be copied, meaning another drug company can make a generic copy of the drug. (Marketing exclusivity is the period of time during which FDA will not approve a generic copy of the approved brand name animal drug.)

While the Green Book is mainly used by companies wanting to manufacture and distribute generic animal drugs, it is also a resource for the public. Besides containing information about patents and exclusivity periods, various sections of the Green Book sort approved animal drugs alphabetically by trade name, numerically by application number (lowest to highest), and alphabetically by active ingredient.

Additional Information

Animal Drugs @ FDA
	Animal Drugs @ FDA Explained
	Recent Animal Drug Approvals
	Approved Animal Drug Products (Green Book) Corrections
	New Animal Drug Applications
	User Fees
	Electronic Submissions
	Electronic Animal Drug Product Listing DirectoryReporting Problems

How to Report Animal Drug and Device Side Effects and Product Problems
	Veterinary Adverse Event Reporting for Manufacturers

                                                                                  Content current as of:
      01/31/2023Approved Animal Drug Products (Green Book)                
                          

                        Freedom of Information (FOI) Summaries for Approved and Conditionally Approved Animal Drugs
          Recent Animal Drug Approvals


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