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FY 2020 GDUFA Fee Rates


Applications

Abbreviated New Drug Application (ANDA) $176,237

Drug Master File (DMF) $57,794

Facilities

Active Pharmaceutical Ingredient (API) Domestic $44,400

Active Pharmaceutical Ingredient (API) Foreign $59,400

Finished Dosage Form (FDF) Domestic $195,662

Finished Dosage Form (FDF) Foreign $210,662

Contract Manufacturing Organization (CMO) Domestic $65,221

Contract Manufacturing Organization (CMO) Foreign $80,221

GDUFA Program

Large size operation generic drug applicant 20+ ANDAs $1,661,684

Medium size operation generic drug applicant 6-19 ANDAs $664,674

Small business operation generic drug applicant 1-5 ANDAs $166,168


Federal Register July 26, 2019

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