EA Review #1, NDA 20-358

Page 2

1.

Date:

          EA dated:    

18 April 1994

          NDA Submitted:

28 February 1994

          Consult

          to HDA-102:

31 May 1994

          Assigned:

11 August 1994

          CSO:

Paul David HFD-120

          Adequate.

2.

Name of Applicant/Petitioner:

          Burroughs Wellcome Co.

          Adequate

3.

Address:

          3030 Cornwallis Road

          Research Triangle Park, NC 27709

          Adequate.

4.

Description of the proposed action:

a.       Requested Approval:

          Burroughs Wellcome Co., has filed a new drug application for approval to manufacture,           package, and market WELLBUTRIN (bupropion hydrochloride) sustained-release tablets           containing 50, 100, and 150 mg of bupropion hydrochloride for the treatment of depression.

          The description of the request should mention the NDA number.

          DEFICIENT