REVIEW AND EVALUATION OF CLINICAL DATA

 

Application Information

               

NDA #2-358

 

                Sponsor: Burroughs Wellcome Co.

 

                Clock Date: March 7, 1994

 

Drug Name

               

                Generic Name: Bupropion hydrochloride

 

                Proposed Trade Name: Wellbutrin SR (rejected)

 

Drug Characterization

 

                Pharmacological Category: Antidepressant

               

                Proposed Indication: Treatment of depressive orders

 

                NDA Classification: 3S

 

                Dosage Forms, Strengths, and Routes of Administration:

                                Oral tablets in 50, 100, and 150 milligram strengths

 

Reviewer Information:

 

                Clinical Reviewer: Dan A. Oren, M.D.

 

                Review Completion Date: November 14, 1994

 

 

 

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