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How to use or fill out FDA Form 2301 with DocHub
- Click ‘Get Form’ to open FDA Form 2301 in our editor.
- Begin by entering the NADA or ANADA number in the first field. If it has fewer than six digits, add leading zeros for proper formatting.
- Fill in the applicant's name and the submission date. Ensure that you also specify the due date for the report.
- Provide the drug trade name and chemical name in their respective fields.
- If applicable, indicate if this is a combined report by listing all relevant NADA numbers.
- Select the type of report from the options provided, such as annual or promotional material.
- Complete sections regarding adverse drug experiences and clinical data as required, checking 'None' if applicable.
- Finally, ensure to fill out your contact information, including email and phone number, before signing off on the form.
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