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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

In this section: Drug Master Files (DMFs)

List of Drug Master Files (DMFs)

The list of DMFs, which is updated quarterly, contains DMFs RECEIVED by December 31, 2024, for which acknowledgment letters were sent before January 13, 2025.

The list is current through DMF 041157. Changes to the DMF activity status (A=active ; I=inactive), DMF type, holder name and subject (title) made since the last update of September 30, 2024, are included.

4Q2024 Excel (XLS - 1.93 MB)

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