Get 356h Form

The 356h Form is essential for applying to market a new or abbreviated new drug or biologic for human use. This guide offers a detailed walkthrough for users on how to complete this form online, ensuring clarity and ease throughout the process.

Follow the steps to effectively fill out the 356h Form online:

1. Click ‘Get Form’ button to obtain the form and open it in the editor.
2. Provide the date of submission in the format mm/dd/yyyy.
3. Enter the name of the applicant in the designated section.
4. Fill in the applicant's telephone number, including country code and area code.
5. Include the facsimile (FAX) number, also with the necessary codes.
6. Complete the applicant address details, including street address, city, state, and ZIP code.
7. If applicable, provide information for the authorized U.S. agent, including their address and contact details.
8. Specify the application number and supplement number if applicable.
9. Identify the established name, proprietary name, and chemical or biochemical name in the relevant fields.
10. Fill in the dosage form, strengths, and route of administration.
11. Provide the proposed indication for use and indicate if it is for a rare disease.
12. Select the application type from the given options.
13. Clarify the submission type and ensure to check all applicable items contained in the application.
14. Complete certification statements and ensure to provide the typed name, title, and contact information for the responsible official.
15. Save your changes, and upon completion, you can download, print, or share the filled form.

Begin completing your 356h Form online today to ensure a seamless submission process.