NDA 21-515                                         Approval Letter                                                 7

 

 

If you have any questions, please call Doris J. Bates, Ph.D., Regulatory Project Manager, at 301-594-2850.

 

Sincerely,

 

{see appended electronics signature page}

 

Russell Katz, M.D.

Director

Division of Neuropharmacological Drug Products

Office of Drug Evaluation I

Center for Drug Evaluation and Research

 

 

 

Enclosure (Revised Draft Labeling) [Please note: the electronic signature page will follow the labeling.]

 

 

Stamped: APPEARS THIS WAY ON ORIGINAL

 

 

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