Food and Drug Administration

                                Rockville, MD 20857

 

NDA 21-515

 

GlaxoSmithKline

Attention: Mary E. Martinson

Director, Psychiatry Regulatory Affairs, 5.5206

PO Box 13398

Five Moore Drive

Research Triangle Park, NC 27709

 

Dear Ms. Martinson:

 

We acknowledge receipt on July 3, 2003 of your July 3, 2003 resubmission to your new drug application for Wellbutrin XL (bupropion) extended-release Tablets.

 

We consider this a complete, Class 1 response to our June 24, 2003 approvable action letter.  Therefore, the user fee goal date for this submission is September 3, 2003.

 

If you have any questions, please call the undersigned, at (301) 594-2850.

 

                        Sincerely,

                        {see appended electronic signature page}

                       

                        Doris J. Bates, Ph.D.

                        Regulatory Project Manager

                        Division of Neuropharmacological Drug

                        Products

                        Office of Drug Evaluation I

                        Center for Drug Evaluation and Research

 

STAMPED: APPEARS THIS WAY ON ORIGINAL

 

 

Back a Page
Next Page
Back to Wellbutrin XL NDA Index Page
Back to Main Index Page