Russell G. Katz, M.D.

August 21, 2003

Page 2

 

 

 

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We are providing a pdf version of the labeling as the base copy all accepted changes from the August 19, 2003 email communication from FDA.  The addition of the website and toll-free number are depicted in the line-revisioned version.  A clean copy of the labeling in pdf and WORD97 version as a review aid are also provided.

 

This submission is being provided electronically in accordance with the Guidance for Industry, Providing Regulatory, Submissions in Electronic Format-NDAs, January 1999.  Pleas see Guide to Reviewers for detailed information about this electronic submission.

 

If you have any questions concerning this submission, please contact me at (919) 483-3763.  Thank you.

 

Sincerely,

(signature)

 

Mary E. Martinson

Director

Regulatory Affairs, Psychiatry

 

cc. Richardae Taylor, HFD-120 (cover letter only)

 

 

 

 

 

 

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