Fda form 3794-2026

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346 votes

The document provides detailed instructions for completing Form FDA 3794, which is required for various submissions related to generic drugs, including Abbreviated New Drug Applications (ANDAs), Prior Approval Supplements (PAS), and Type II Active Pharmaceutical Ingredient (API) Drug Master Files (DMFs). It outlines the necessary information to be included in the form, such as applicant details, user fee types, application numbers, and facility information. The document also specifies exemptions for certain drug types and includes guidance on payment processing.

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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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Versions	Form popularity	Fillable & printable
2013	4.8 Satisfied (118 Votes)
2012	4.4 Satisfied (346 Votes)

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