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Chemistry Assessment Section

 

Chemistry Review Data Sheet

 

1.     NDA 21-515

2.     REVIEW #3

3.     REVIEW DATE: 8/15/03

4.     REVIEWER: Sherita McLamore, Ph.D.

5.     PREVIOUS DOCUMENTS

 

Previous Documents                                    Document Date

Original Submission                                     8/26/02

Amendment                                                2/11/03

Amendment                                                4/17/03

CMC Review #1                                         6/10/03

CMC Review #2                                         6/10/03

 

6.     SUBMISSION(S) BEING REVIEWED:

 

Submission(s) Reviewed                              Document Date

Response to Approvable letter                      7/03/03

 

 

7.     NAME & ADDRESS OF APPLICANT

 

                                                   Name:  GlaxoSmithKline

                                                               One Franklin Plaza

                                                Address:  P.O. Box 7929

                                                               Philadelphia, PA 19101

 

                                       Representative: Mary E. Martinson

 

                                             Telephone: 919.315.8319

 

 

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