FDA Drug Master Files
The FDA publishes this list once a quarter. Search by DMF number, holder or subject, and filter by type and status.
Loading Drug Master File summary…
Loading Drug Master Files…
The FDA publishes this list once a quarter. Search by DMF number, holder or subject, and filter by type and status.
Drug Master Files
41,253
in the current quarterly list
Active
22,373
54% of the list
Inactive
18,879
46% of the list
Holders
9,057
distinct holder names
Source: FDA Drug Master Files · loaded Sep 4, 2026