Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Abbreviated New Animal Drug Applications

Abbreviated New Animal Drug Applications

                        Bioequivalence
          Suitability Petitions Home
          Animal & Veterinary
          Development & Approval Process
          Abbreviated New Animal Drug Applications
          Suitability PetitionsAbbreviated New Animal Drug Applications Suitability Petitions
  
  	
    Share
    Post
    Linkedin

    Email
    PrintA suitability petition is a request by a drug sponsor (called the “petitioner”) to submit an abbreviated new animal drug application (ANADA) for a proposed generic new animal drug that differs from the reference listed new animal drug (RLNAD).  Permissible changes provided under § 512(n)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C act) include:

Route of administration;
	Dosage form;
	Strength (concentration);
	A change in one of the active ingredients in the reference listed combination new animal drug (same pharmaceutical class); or
	whose use with other animal drugs in animal feed differs from that of an approved new animal drug.Suitability petitions are a type of Citizen Petition and are submitted through the Division of Dockets Management. Please refer to 21 CFR 10.30 for details on how to submit a suitability petition.

Below is a list of the type of information we need to make a determination about your suitability petition.  We have received this information in table and other formats.

Identification of the petitioner, including name, address, phone number, and email address, and a citation to § 512(n)(3) of the FD&C act as the basis for the suitability petition;
	Action requested:  Identification of the proposed generic product and a description of the permissible change(s) being requested;
	Identification of the requested RLNAD, including dosage form; strength, & active ingredient(s);
	Comprehensive statement of grounds (justification) for the proposed change from the RLNAD being requested;
	Side-by-side comparison of suggested label changes for the proposed generic new animal drug and the currently approved labeling for the RLNAD;
	Request for a categorical exclusion under 21 CFR 25.30(h) from the requirement to prepare an environmental assessment or an environmental assessment under 21 CFR 25.40;
	If requested by the Commissioner following review of the petition, an economic impact statement. The petitioner must indicate that such an analysis will be provided upon request; and
	Certification that this petition includes, to the best knowledge and belief of the petitioner, all information and views on which the petition relies, and that it includes representative data and information known to the petitioner, which are unfavorable to the petition.The Policy and Procedures 1243.3040 document entitled Processing Suitability Petitions is publicly available. This manual provides additional information about the suitability petition process.

                                                                                  Content current as of:
      01/24/2024Abbreviated New Animal Drug Applications

          
                        Bioequivalence
          Suitability Petitions
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop