> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Generic Drug User Fee Rates for FY 2025
- URL: https://www.fdaweb.com/generic-drug-user-fee-rates-for-fy-2025/
- Published: 2024-07-30T12:00:00.000Z
- Updated: 2026-09-14T14:36:50.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5157465

*Federal Register* notice: FDA is announcing fiscal year 2025 rates for generic drug user fees. They are:

- ANDA — $321,920
- Drug master file — $95,084
- Active pharmaceutical ingredient (API) domestic facility — $41,580
- API foreign facility — $56,580
- Finished dosage form (FDF) domestic — $231,952
- FDF foreign — $246,952
- Contract manufacturing organization (CMO) domestic — $55,668
- CMO foreign — $70,668
- GDUFA program (large operation) —$1.9 million
- GDUFA program (medium operation) — $756,666
- GDUFA program (small operation) — $189,166

To view the notice, click [here](https://public-inspection.federalregister.gov/2024-16896.pdf?ref=fdaweb.com).