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- Click ‘Get Form’ to open FDA Form 3794 in the editor.
- Begin by filling out the 'Applicant, Holder or Owner' section. Enter the legal name and address of the entity that owns or controls the submission.
- In the 'Representative or U.S. Agent' field, provide contact details for a person authorized to respond to inquiries regarding this cover sheet.
- Indicate the applicable fiscal year for your payment, which runs from October 1 to September 30.
- Select the type of generic drug user fee by checking the appropriate box under 'Generic Drug User Fee Type'.
- For ANDA submissions, enter the six-digit application number. Ensure you include leading zeroes if necessary.
- Complete all relevant sections regarding API manufacturing information and facility details as required.
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