Changes in Manufacturer's Name and or Product Name - Administrative Changes - Certification Form

1. Nature of Change (Please check one)

Change in Manufacturer's Name
Change in Product Name
Change in Manufacturer's Name and Product Name

2. Reason for Change (Please check one)
(Please check one)

Merger/Buy-out.
Same DIN may be retained.
New DIN ..... Same DIN .....

Product name change only.
Same DIN may be retained, unless this application
is for an alternate brand name.
New DIN ..... Same DIN .....

Licensing agreement (original DIN owner to cease sale
of product). Same DIN may be retained by second firm
New DIN ..... Same DIN .....

Licensing agreement (2 firms to market the same
product). New DIN will be issued to the second firm.
(New DIN will be issued)

Copy of the latest Drug Notification form and marketed labelling enclosed

Copy of Letter of Authorization for Licensing agreements

Copy of proper documentation to show the legal change in company

We certify that all aspects of the submission pertaining to:

(name of product)

submitted by:

(name of manufacturer)

are identical to the

(name of current product, current name of manufacturer)

(current DIN)

submission except for a change in the manufacturer/sponsor's name and/or product name and that for new drugs, the product will be manufactured in the same location with identical specifications and procedures.

Name of Authorized Signing Official and Title

Signature

Company of new DIN owner Date

Telephone No. Facsimile No.
E-mail address