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In this section: Generic Drug User Fee Amendments

User Fee Lists

Annual facility fees and Generic Drug Applicant Fees are due October 1st of each applicable FY.

Generic Drug Applicant Program Fee Arrears List (PDF)
Generic Drug Applicant Program Fee Arrears List (XLS)
GDUFA Facility Arrears List (PDF)
GDUFA Facility Arrears List (XLS)
GDUFA Facilities with Outstanding Fees Not on the Arrears List (PDF)
GDUFA Facilities with Outstanding Fees Not on the Arrears List (XLS)
Type II Drug Master Files - Available for Reference List
GDUFA Backlog Arrears List
GDUFA Paid Facilities List

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