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Form 3794-2026
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- Click ‘Get Form’ to open Form FDA 3794 in the editor.
- Begin by filling out the 'APPLICANT, HOLDER OR OWNER' section with the legal name and address of the entity submitting the application.
- In the 'REPRESENTATIVE OR U.S. AGENT' field, provide contact details for a person authorized to respond to FDA inquiries, ensuring they are a U.S. agent if applicable.
- Indicate the relevant 'FISCAL YEAR' for your submission, noting that it starts on October 1 of the previous calendar year.
- Select the appropriate 'GENERIC DRUG USER FEE TYPE' by checking the corresponding box for ANDA, PAS, Type II API DMF, or backlog fee.
- Complete sections related to ANDA/PAS information by entering application numbers and product names as required.
- Fill in facility information including name, address, FEI number, and DUNS number as necessary.
- Review all entries for accuracy before submitting your completed form through our platform.
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