> ## 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.

# FY 2019 Generic Drug User Fees Set
- URL: https://www.fdaweb.com/fy-2019-generic-drug-user-fees-set/
- Published: 2018-07-27T12:00:00.000Z
- Updated: 2026-09-15T00:22:16.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141984

*Federal Register* notice: FDA has announced the fiscal year 2019 rates for generic drug program areas. For FY 2019, rates are: ANDA ($178,799), Drug Master File ($55,013), domestic Active Pharmaceutical Ingredient (API) facility ($44,226), foreign API facility ($59,226), domestic Finished Dosage Form (FDF) facility ($211,305), foreign FDF facility ($226,305), domestic Contract Manufacturing Operation (CMO) facility ($70,435), foreign CMO facility ($85,435), large size operation generic drug applicant program ($1,862,167), medium size operation generic drug applicant program ($744,867), and small business generic drug applicant program ($186,217). To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-07-27/pdf/2018-16067.pdf?ref=fdaweb.com).