HOLDER NAME CHANGE Letter
No Cover (Transmittal) Letter necessary
Notes are in bold font. Information to be filled in is in italics
Date: Enter the date of the Submission
DMF#: Enter the DMF number
Holder: Enter the Original Name of Holder
Subject: Enter the Subject of the DMF as it appears on the DMF Web site. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/Drug
Submission Information: General Information/Administrative/Change in Holder: Internal Name
New Holder Name: Enter the New Name of Holder
Include the following:
Information regarding the change in Name of holder
Signature of Responsible Official Enter
Name of Responsible Official Responsible Official’s Title
Responsible Official’s Company Name i.e. Holder Responsible Official’s Telephone number
Responsible Official’s Fax number
Responsible Official’s e-mail address
This letter must come from the Holder. Letters from the U.S. Agent are not accepted for Holder Name Change Letters.
Use this letter ONLY when there is an internal name change. Do not use when a DMF is transferred from one company to another.
The letter must be on the letterhead reflecting the name change.