[Logo CDER]          CHEMISTRY REVIEW TEMPLATE                 [Logo CDER]

Chemistry Assessment Section

 

 

CHEMISTRY REVIEW DATA SHEET

 

1.     NDA 21-515

 

2.     REVIEW #4

 

3.     REVIEW DATA 8/29/03

 

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

CMC Review #3                                                                 8/16/03

 

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

 

8.     DRUG PRODUCT NAME/CODE/TYPE:

 

 

 

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