How much is ANDA fee?

ANDA  fee for FY 2019  are as below.

 

ANDA fee –     $ 178,799 . This fee is applicable for each ANDA.

ANDA Program fee – This is the annual for ANDA holder.

Large Size $       1,862,167
Medium Size $           744,867
Small Size $           186,217

 

Large: 20 or more approved ANDAs;
Medium:  between 6 and 19 approved ANDAs;
Small: 5 or fewer approved ANDAs

Facility Fee – Annual fee for each facility involved in the ANDA

Domestic API $             44,226
Foreign API $             59,226
Domestic FDF $           211,305
Foreign FDF $           226,305
Domestic CMO $             70,435
Foreign CMO $            85,435

 

API – Active Pharmaceutical Ingredient (drug substance manufacturer)

FDF – Finished Dosage Manufacturer

CMO – Contract Manufacturing Organization

Drug Master File fee     55,013 , only applicable for Type II DMF

 

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