[Logo - CDER] CHEMISTRY REVIEW TEMPLATE
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Chemistry Assessment Section
Chemistry Review Data Sheet
1.
NDA
21-515
2.
REVIEW
#1
3.
REVIEW
DATE: 5/23/03
4.
REVIEWER:
Sherita McLamore, Ph.D.
5.
PREVIOUS
DOCUMENTS
Previous Documents Document
Date
None
6.
SUBMISSION(S)
BEING REVIEWED:
Submission(s) Reviewed Document Date
Original Submission 8/26/02
Amendment 2/11/03
Amendment 4/17/03
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:
Page 4 of 4444
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