Get Fda Form 2301

Filling out the Fda Form 2301 is essential for transmitting periodic reports and promotional material for new animal drugs. This guide provides clear, step-by-step instructions to assist you in completing the form efficiently and accurately.

Follow the steps to complete the form online.

1. Click the ‘Get Form’ button to obtain the form and open it in a digital editor.
2. Enter the NADA number or ANADA number assigned to the drug in the first field. If it contains fewer than six digits, prepend leading zeros to ensure it matches the required format.
3. In the second field, input the name of the applicant responsible for the submission.
4. Specify the date the report is being submitted in the provided format.
5. Indicate the due date for the report in the designated field.
6. Provide the drug trade name in the relevant section.
7. Input the chemical name of the drug as required.
8. If submitting a combined report, list all related NADA numbers involved in the report.
9. Fill in the report period section with the respective starting and ending dates.
10. Select the type of report by checking the appropriate box from the options provided, such as ‘6/12/18/24 Month’, ‘Annual’, or ‘Promo/Ad’.
11. For information regarding periodic and special requirements, check the boxes corresponding to adverse drug experiences, clinical data, mailing pieces, current package labeling, and quantity marketed as needed.
12. If applicable, provide promotional material details such as date of issuance, type of material, and identification code.
13. Input the name and title of the responsible official or US agent in the designated field.
14. Affix the signature of the above official or agent, ensuring it is legible.
15. Enter the email address of the applicant or agent for communication regarding the form.
16. Finally, provide the telephone and fax number of the applicant or agent for follow-ups.
17. Once all fields have been accurately completed, save the changes, and choose to download, print, or share the form as necessary.

Complete your Fda Form 2301 online today for efficient document management.