EA Review #2, NDA 20-358 Page 1
ENVIRONMENTAL ASSESSMENT
1.
Date:
|
EA dated: |
April 18, 1994 |
|
Consult #1: |
May 31, 1994 |
|
Review #1: |
January 10, 1995 |
|
NA letter: |
May 25, 1995 |
|
EA dated: |
July 27, 1995* (cover letter 9/2/95) |
|
Consult: |
October 2, 1995 |
|
* Information reviewed |
|
|
CSO: |
Paul David |
2.
Name of Applicant/Petitioner:
Burroughs Wellcome Co.
3.
Address:
3030
Cornwallis Road
Research
Triangle Park, NC 27709
Note: A conference call was held on July 10, 1995,
at the request of the company, to clarify some of the deficiencies. The (rest of section whited out)
RESPONSE TO REVIEW #1 DEFICIENCIES:
4.a. The NDA number has been included as requested: ADEQUATE
4.b. A
discussion of the benefit of sustained release tablets has been added. ADEQUATE
4.c.
i.
There
are no proprietary intermediates. ADEQUATE
ii.
The requested address has been provided. ADEQUATE
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