Get Fda 2301 2021-2025

Filling out the FDA 2301 is crucial for submitting periodic reports and promotional materials for new animal drugs. This guide provides a clear, step-by-step approach to ensure accuracy and compliance with the regulations.

Follow the steps to successfully complete the FDA 2301 online.

1. Press the ‘Get Form’ button to access the online form and open it in your preferred editor.
2. Enter the NADA or ANADA number in the corresponding field. If the number has fewer than six digits, make sure to add leading zeros to meet the six-digit requirement.
3. Fill in the 'Name of Applicant' section with the name of the entity or individual submitting the report.
4. Provide the 'Date Report Submitted' and 'Date Report Due' using the appropriate date format (MM/DD/YYYY).
5. Enter the 'Drug Trade Name' and the 'Chemical Name' of the new animal drug in the respective fields.
6. If applicable, check the box for a 'Combined Report' and list the relevant NADA numbers involved. Refer to the instructions for guidance.
7. Indicate the report period by filling out the 'From' and 'To' fields with the appropriate dates.
8. Select the 'Type of Report' by checking one of the options (e.g., 6/12/18/24 Month, Follow Up, Annual, Promo/Ad, Other).
9. Complete Section 10 with the required information regarding adverse drug experiences, clinical data, mailing pieces, and current package labeling, and provide additional details on a separate sheet if necessary.
10. For promotional material, fill out Section 11 with the date of issuance, type of material, and identification code.
11. In Section 12, provide the name and title of the responsible official or U.S. agent, and ensure it is typed or printed clearly.
12. Include the signature of the above official or agent in Section 13.
13. Fill in the email address and telephone & fax number of the applicant or agent in the respective fields.
14. Once all sections are completed, ensure to save your changes. You may download, print, or share the form as required.

Complete your FDA 2301 form online today for compliance and timely submission.