For FY 2023, the FDA generic drug User Fee rates are: ANDA ($240,582), DMF ($78,293), domestic API facility ($37,544), foreign API facility ($52,544), domestic FDF facility ($213,134), foreign FDF facility ($228,134), domestic CMO facility ($51,152), foreign CMO facility ($66,152), large size operation generic drug applicant program ($1,620,556), medium size operation generic drug applicant program ($648,222), and small business generic drug applicant program ($162,056).
These fees are effective on October 1, 2022, and will remain in effect through September 30, 2023.
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