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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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